- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01374425
Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC) (MAVERICC)
torstai 30. kesäkuuta 2016 päivittänyt: Genentech, Inc.
MAVERICC (Marker Evaluation for Avastin Research in CRC): A Randomized Phase II Study of Bevacizumab+mFOLFOX6 Vs. Bevacizumab+FOLFIRI With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer
This will be a randomized, open-label, multicenter, Phase II study with primary objectives to assess whether expression of select chemotherapy markers is associated with progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI).
The study population will consist of participants with first-line mCRC.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
376
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
-
Cork, Irlanti
-
Dublin, Irlanti, 24
-
Galway, Irlanti
-
-
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G 1Z2
-
-
-
-
-
Oslo, Norja, 0407
-
-
-
-
-
Coimbra, Portugali, 3000-075
-
Lisboa, Portugali, 1649-035
-
Porto, Portugali, 4200-072
-
-
-
-
-
Aarau, Sveitsi, 5000
-
Basel, Sveitsi, 4031
-
Luzern, Sveitsi, 6004
-
Zürich, Sveitsi, 8063
-
-
-
-
-
Tallinn, Viro, 13419
-
Tartu, Viro, 51014
-
-
-
-
Alabama
-
Birmingham, Alabama, Yhdysvallat, 35294
-
-
Arkansas
-
Little Rock, Arkansas, Yhdysvallat, 72205-7199
-
-
California
-
Bellflower, California, Yhdysvallat, 90706
-
Duarte, California, Yhdysvallat, 91010
-
Fountain Valley, California, Yhdysvallat, 92708
-
Fresno, California, Yhdysvallat, 93720
-
Hayward, California, Yhdysvallat, 94545
-
Los Angeles, California, Yhdysvallat, 90033
-
Oakland, California, Yhdysvallat, 94611
-
Pleasant Hill, California, Yhdysvallat, 94523
-
Roseville, California, Yhdysvallat, 95661
-
Sacramento, California, Yhdysvallat, 95817
-
Sacramento, California, Yhdysvallat, 95825
-
San Francisco, California, Yhdysvallat, 94115
-
San Jose, California, Yhdysvallat, 95119
-
Santa Clara, California, Yhdysvallat, 95051
-
South San Francisco, California, Yhdysvallat, 94080
-
Vallejo, California, Yhdysvallat, 94589
-
Walnut Creek, California, Yhdysvallat, 94596
-
-
Colorado
-
Denver, Colorado, Yhdysvallat, 80218
-
-
Connecticut
-
Stamford, Connecticut, Yhdysvallat, 06902
-
Trumbull, Connecticut, Yhdysvallat, 06611
-
-
Florida
-
Hollywood, Florida, Yhdysvallat, 33021
-
Jacksonville, Florida, Yhdysvallat, 32256
-
Miami, Florida, Yhdysvallat, 33136
-
Port Saint Lucie, Florida, Yhdysvallat, 34952
-
-
Idaho
-
Boise, Idaho, Yhdysvallat, 83712
-
-
Illinois
-
Joliet, Illinois, Yhdysvallat, 60435
-
Maywood, Illinois, Yhdysvallat, 60153
-
Peoria, Illinois, Yhdysvallat, 61615
-
-
Indiana
-
Goshen, Indiana, Yhdysvallat, 46526
-
Indianapolis, Indiana, Yhdysvallat, 46237
-
Terre Haute, Indiana, Yhdysvallat, 47802
-
-
Kansas
-
Fairway, Kansas, Yhdysvallat, 66205
-
-
Kentucky
-
Elizabethtown, Kentucky, Yhdysvallat, 42791
-
-
Maine
-
Scarborough, Maine, Yhdysvallat, 04074
-
-
Massachusetts
-
Burlington, Massachusetts, Yhdysvallat, 01805
-
-
Montana
-
Billings, Montana, Yhdysvallat, 59102
-
-
Nebraska
-
Lincoln, Nebraska, Yhdysvallat, 68506
-
-
New Jersey
-
Cherry Hill, New Jersey, Yhdysvallat, 08003
-
Manasquan, New Jersey, Yhdysvallat, 08736
-
-
New Mexico
-
Albuquerque, New Mexico, Yhdysvallat, 87131-5636
-
Albuquerque, New Mexico, Yhdysvallat, 87106
-
Albuquerque, New Mexico, Yhdysvallat, 87110
-
Farmington, New Mexico, Yhdysvallat, 87401
-
Las Cruces, New Mexico, Yhdysvallat, 88011
-
Santa Fe, New Mexico, Yhdysvallat, 87505
-
-
New York
-
Rochester, New York, Yhdysvallat, 14642
-
-
North Carolina
-
Durham, North Carolina, Yhdysvallat, 27710
-
Greensboro, North Carolina, Yhdysvallat, 27403
-
High Point, North Carolina, Yhdysvallat, 27262
-
Washington, North Carolina, Yhdysvallat, 27889
-
Winston-salem, North Carolina, Yhdysvallat, 27103
-
-
Ohio
-
Columbus, Ohio, Yhdysvallat, 43219
-
Toledo, Ohio, Yhdysvallat, 43623
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Yhdysvallat, 73142
-
-
Pennsylvania
-
Dunmore, Pennsylvania, Yhdysvallat, 18512
-
Media, Pennsylvania, Yhdysvallat, 19063
-
Philadelphia, Pennsylvania, Yhdysvallat, 19107
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15212
-
-
South Carolina
-
Charleston, South Carolina, Yhdysvallat, 29414
-
-
Texas
-
Corpus Christi, Texas, Yhdysvallat, 78404
-
Houston, Texas, Yhdysvallat, 77090
-
-
Wisconsin
-
Madison, Wisconsin, Yhdysvallat, 53792
-
Wauwatosa, Wisconsin, Yhdysvallat, 53226
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Histologically or cytologically confirmed colorectal cancer (CRC) with at least one measurable metastatic lesion by RECIST Version 1.1
- Archival tumor tissue sample must be requested and available prior to study entry. If no archival tumor tissue sample is available, a fresh biopsy tissue sample must be obtained but should be discussed first with the medical monitor. A copy of the local pathology report must be submitted along with the specimens.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants with treated brain metastases are eligible for study participation. Participants may not receive ongoing treatment with steroids at Screening. Anticonvulsants (at stable dose) are allowed. Treatment for brain metastases may be whole-brain radiotherapy, radiosurgery, neurosurgery, or a combination as deemed appropriate by the treating physician. Radiotherapy and stereotactic radiosurgery must be completed at least 28 days prior to randomization.
- Female participants should not be pregnant or breastfeeding. Female participants with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs. Female participants with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study.
- Male participants must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs, even if they have been surgically sterilized.
Exclusion Criteria:
- Any prior systemic treatment for mCRC
- Adjuvant chemotherapy for CRC completed <12 months
- Evidence of Gilbert's syndrome or of homozygosity for the UGT1A1*28 allele
- Known positivity for human immunodeficiency virus (HIV)
- Malignancies other than mCRC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
- Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
- Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry
- Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Bevacizumab + mFOLFOX6
Participants will receive bevacizumab plus mFOLFOX6 by intravenous (IV) infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity.
Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin, with bevacizumab continued in 3-week cycles.
|
5-Fluorouracil 400 milligrams per meter-squared (mg/m^2) by IV bolus and subsequent 2400 mg/m^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity.
If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.
Muut nimet:
Leucovorin 400 mg/m^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Oxaliplatin 85 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Capecitabine 850 or 1000 mg/m^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.
|
Kokeellinen: Bevacizumab + FOLFIRI
Participants will receive bevacizumab plus FOLFIRI by IV infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity.
Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan, with bevacizumab continued in 3-week cycles.
|
5-Fluorouracil 400 milligrams per meter-squared (mg/m^2) by IV bolus and subsequent 2400 mg/m^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity.
If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.
Muut nimet:
Leucovorin 400 mg/m^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Capecitabine 850 or 1000 mg/m^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.
Irinotecan 180 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm).
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Overall Survival (OS)
Aikaikkuna: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
OS in Participants With High ERCC-1 Levels
Aikaikkuna: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
OS in Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Disease Control According to RECIST Version 1.1
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS
Aikaikkuna: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Tumor assessments were performed according to RECIST Version 1.1.
Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm.
Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy.
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
PFS was defined as the time from randomization to death or disease progression, whichever occurred first.
The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Aikaikkuna: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Aikaikkuna: From Baseline until death (maximum up to 45 months overall)
|
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment.
OS was defined as the time from randomization to death.
The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months.
The 95% CI was computed using the method of Brookmeyer and Crowley.
|
From Baseline until death (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Objective response was defined as CR or PR according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
The percentage of participants with CR or PR was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Aikaikkuna: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1.
CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes.
PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline.
Confirmation of response at a consecutive assessment was not required.
SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study.
The percentage of participants with CR, PR, or SD was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
|
Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins.
In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1.
R2 was defined as macroscopic positive margins or incomplete resection at time of surgery.
The percentage of participants with resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Aikaikkuna: At time of resective surgery during study (maximum up to 45 months overall)
|
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator.
Resection was classified as R0, R1, or R2 following surgery.
R0 was defined as complete resection with clear margins ≥1 mm.
The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported.
The 95% CI was computed using normal approximation to the binomial distribution.
|
At time of resective surgery during study (maximum up to 45 months overall)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Christiane Langer, M.D., Genentech, Inc.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. elokuuta 2011
Ensisijainen valmistuminen (Todellinen)
Perjantai 1. toukokuuta 2015
Opintojen valmistuminen (Todellinen)
Keskiviikko 1. heinäkuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 14. kesäkuuta 2011
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 15. kesäkuuta 2011
Ensimmäinen Lähetetty (Arvio)
Torstai 16. kesäkuuta 2011
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 11. elokuuta 2016
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 30. kesäkuuta 2016
Viimeksi vahvistettu
Keskiviikko 1. kesäkuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Ruoansulatuskanavan sairaudet
- Neoplasmat
- Neoplasmat sivustoittain
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Paksusuolen sairaudet
- Suoliston sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Kolorektaaliset kasvaimet
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Entsyymin estäjät
- Antimetaboliitit, antineoplastiset
- Antimetaboliitit
- Antineoplastiset aineet
- Immunosuppressiiviset aineet
- Immunologiset tekijät
- Suojaavat aineet
- Topoisomeraasin estäjät
- Antineoplastiset aineet, immunologiset
- Angiogeneesin estäjät
- Angiogeneesiä moduloivat aineet
- Kasvuaineet
- Kasvun estäjät
- Mikroravinteet
- Vitamiinit
- Topoisomeraasi I:n estäjät
- Vastalääkkeet
- B-vitamiinikompleksi
- Fluorourasiili
- Kapesitabiini
- Oksaliplatiini
- Bevasitsumabi
- Leukovoriini
- Irinotekaani
Muut tutkimustunnusnumerot
- ML25710
- 2011-004755-39 (EudraCT-numero)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Peräsuolen syöpä
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)ValmisLymfaödeema | Perioperatiiviset/postoperatiiviset komplikaatiot | Vaiheen II Vulvar Cancer AJCC v7 | Vaihe IIIA Vulvar Cancer AJCC v7 | Vaihe IIIB Vulvar Cancer AJCC v7 | Vaihe IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Vaihe IA Vulvar Cancer AJCC v7 | Vaihe IB Vulvar Cancer AJCC v7 | Vaihe...Yhdysvallat
-
Fore BiotherapeuticsRekrytointiCancer sisältää BRAF-muutoksiaYhdysvallat, Saksa, Espanja, Yhdistynyt kuningaskunta, Ranska, Korean tasavalta, Italia, Ruotsi, Kanada
-
Samsung Medical CenterValmisHER2-positiivinen Refractory Advanced CancerKorean tasavalta
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiVaiheen III vulvar Cancer AJCC v7 | Vaihe IIIA Vulvar Cancer AJCC v7 | Vaihe IIIB Vulvar Cancer AJCC v7 | Vaihe IIIC Vulvar Cancer AJCC v7 | Epäsuoran levyepiteelisyöpä | Stage IVA Vulvar Cancer AJCC v7Yhdysvallat
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RekrytointiVaiheen II Vulvar Cancer AJCC v8 | Vaiheen IIIC vulvar Cancer AJCC v8 | Stage IVA Vulvar Cancer AJCC v8 | Kolmannen vaiheen ulkosynnyttäjäsyöpä AJCC v8 | Vaihe IIIA Vulvar Cancer AJCC v8 | Vaihe IIIB Vulvar Cancer AJCC v8Yhdysvallat
-
University of UtahNational Cancer Institute (NCI)RekrytointiVäsymys | Istuva elämäntapa | Metastaattinen eturauhassyöpä | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Eturauhassyöpä AJCC (American Joint Committee on Cancer) v8 | Stage IVB Eturauhassyöpä AJCC (American Joint Committee on Cancer) v8Yhdysvallat
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...ValmisTutki kiinalaisia naisia, jotka eivät ole noudattaneet American Cancer Societyn mammografiaseulontaohjeitaYhdysvallat
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ValmisOhutsuolen adenokarsinooma | Vaihe III ohutsuolen adenokarsinooma AJCC v8 | Vaihe IIIA ohutsuolen adenokarsinooma AJCC v8 | Vaihe IIIB ohutsuolen adenokarsinooma AJCC v8 | IV vaiheen ohutsuolen adenokarsinooma AJCC v8 | Vater-adenokarsinooman ampulla | Vaiheen III ampulla Vater Cancer AJCC v8 | Vaiheen... ja muut ehdotYhdysvallat
-
Massachusetts General HospitalValmisColoRectal syövän seulonta
-
Centre Francois BaclesseLigue contre le cancer, FranceRekrytointiPitkäaikaiset syövän sivuvaikutukset | Tukihoito syövän hoidossa | Cancer Survivorship Care Plan | Edistynyt sairaanhoitaja | Lantion gynekologinen syöpäRanska
Kliiniset tutkimukset 5-Fluorouracil
-
Encube Ethicals Pvt. Ltd.CBCC Global ResearchValmis
-
Uppsala UniversityRekrytointiPeräsuolen syöpä | Peritoneaaliset metastaasitRuotsi
-
Tampere University HospitalValmis
-
Helsinn Healthcare SALopetettuSappiteiden syöpäYhdysvallat, Espanja, Kanada, Ranska, Saksa, Unkari, Italia, Belgia, Puola, Venäjän federaatio, Yhdistynyt kuningaskunta
-
Melissa Pugliano-MauroNational Cancer Institute (NCI)RekrytointiKarsinooma, okasolusoluYhdysvallat
-
National Institute of Public Health, CambodiaEmory University; World Vision International; World Vision, Hong Kong; World...ValmisAlipainoiset lapset 6–23 kuukauden ikäiset (WAZ < -1)Kambodža
-
ClinAmygateAswan University HospitalRekrytointiKolekystolitiaasi | Kolekystiitti; Sappikivi | Kolekystiitti, krooninenEgypti
-
Taipei Medical University Shuang Ho HospitalValmisAlempien virtsateiden oireet | Yliaktiivisen virtsarakon oireyhtymäTaiwan
-
U.S. Army Medical Research and Development CommandRekrytointiStressihäiriöt, posttraumaattisetYhdysvallat
-
Taipei Medical University HospitalValmisPostoperatiiviset komplikaatiot | HaurasTaiwan