- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01765582
Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer (STEAM)
18. srpna 2017 aktualizováno: Hoffmann-La Roche
Steam (Sequencing Triplet With Avastin and Maintenance): FOLFOXIRI/Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
This randomized, open-label, multicenter study will evaluate the efficacy and safety of folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) / bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with metastatic colorectal cancer.
Participants will be randomized to receive bevacizumab 5 milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine until disease progression occurs.
After disease progression, participants will receive treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.
Přehled studie
Postavení
Ukončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
280
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Alabama
-
Mobile, Alabama, Spojené státy, 36604
- University of South Alabama; Mitchell Cancer Institute
-
-
California
-
Long Beach, California, Spojené státy, 90806
- Long Beach Memorial Medical Center; Oncology
-
Los Angeles, California, Spojené státy, 90033
- USC Norris Cancer Center
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Los Angeles, California, Spojené státy, 90033
- LAC-USC Medical Center
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Monterey, California, Spojené státy, 93940
- Pacific Cancer Care - Monterey
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Sacramento, California, Spojené státy, 95816
- Sacramento Center for Hematolo
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Salinas, California, Spojené státy, 93901
- Pacific Cancer Care
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-
Colorado
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Denver, Colorado, Spojené státy, 80205
- Kaiser Permanente - Franklin
-
-
Connecticut
-
New Haven, Connecticut, Spojené státy, 06520
- Yale Cancer Center
-
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District of Columbia
-
Washington, D.C., District of Columbia, Spojené státy, 20016
- Sibley Memorial Hospital
-
-
Florida
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Fort Myers, Florida, Spojené státy, 33905
- Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
-
Saint Petersburg, Florida, Spojené státy, 33705
- Florida Cancer Specialist, North Region
-
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Georgia
-
Athens, Georgia, Spojené státy, 30607
- University Cancer & Blood Center, LLC
-
Atlanta, Georgia, Spojené státy, 30322
- Emory University Clinic
-
Macon, Georgia, Spojené státy, 31201
- Central Georgia Cancer Care PC
-
Savannah, Georgia, Spojené státy, 31405
- Summit Cancer Care PC
-
-
Illinois
-
Harvey, Illinois, Spojené státy, 60426
- Ingalls Memorial Hosp
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Naperville, Illinois, Spojené státy, 60540
- Edward Cancer Center Naperville
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Plainfield, Illinois, Spojené státy, 60585
- Edward Cancer Center Plainfield
-
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Kentucky
-
Lexington, Kentucky, Spojené státy, 40536
- University of Kentucky Medical Center
-
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Maryland
-
Baltimore, Maryland, Spojené státy, 21231
- Johns Hopkins Univ; Bunting Blaustein Cancer Center
-
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Massachusetts
-
Boston, Massachusetts, Spojené státy, 02111
- Tufts Medical Center
-
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Michigan
-
Ann Arbor, Michigan, Spojené státy, 48106
- St. Joseph Mercy Hospital; Cancer Care Center.
-
Detroit, Michigan, Spojené státy, 48201
- Karmanos Cancer Institute..
-
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Missouri
-
Saint Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
-
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Nebraska
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Lincoln, Nebraska, Spojené státy, 68510
- Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
-
Omaha, Nebraska, Spojené státy, 68114
- Nebraska Methodist Hospital; Cancer Center
-
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New Hampshire
-
Lebanon, New Hampshire, Spojené státy, 03756
- Dartmouth Hitchcock Med Center
-
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Ohio
-
Cincinnati, Ohio, Spojené státy, 45242
- Oncology Hematology Care Inc
-
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- University of Oklahoma; Stephenson Oklahoma Canc Ctr
-
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033
- Milton S. Hershey Medical Center; Penn State Cancer Inst.
-
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Tennessee
-
Chattanooga, Tennessee, Spojené státy, 37404
- Chattanooga Oncology and Hematology Associates, PC
-
Germantown, Tennessee, Spojené státy, 38138
- West Clinic
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Nashville, Tennessee, Spojené státy, 37203
- Sarah Cannon Cancer Center and Research Institute
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Texas
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Dallas, Texas, Spojené státy, 75390-9063
- UT Southwestern MC at Dallas
-
Fort Worth, Texas, Spojené státy, 76104
- Ctr For Cancer And Blood Disorders
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Temple, Texas, Spojené státy, 76508
- Scott and White Hospital; Cancer Center
-
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Virginia
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Richmond, Virginia, Spojené státy, 23226
- Virginia Cancer Institute
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Washington
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Kirkland, Washington, Spojené státy, 98034
- Seattle Cancer Care Alliance - Evergreen Health
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Seattle, Washington, Spojené státy, 98109
- Seattle Cancer Care Alliance
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Spokane, Washington, Spojené státy, 99208
- Medical Oncology Associates
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Wisconsin
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Green Bay, Wisconsin, Spojené státy, 54311
- Vince Lombardi Cancer Center
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin; Dept Froedtert Clin Can Ctr
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Wauwatosa, Wisconsin, Spojené státy, 53226
- Aurora Research Institute
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Wyoming
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Cheyenne, Wyoming, Spojené státy, 82001
- Cheyenne Oncology & Hematology Associates
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Histologically confirmed colorectal cancer with at least one measurable metastatic lesion by RECIST v 1.1, that is considered unresectable at baseline
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 if age less than (<) 71 years; ECOG status of 0 if age 71 to 75 years
- Adequate hematological, renal and liver function
- 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
- Females of childbearing potential and males must agree to use effective contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of study drug
Exclusion Criteria:
- Any prior treatment for metastatic colorectal cancer, except for use of palliative radiosensitizers
- Adjuvant chemotherapy for colorectal cancer completed < 12 months prior to study consent
- Sensory peripheral neuropathy greater than or equal to (>/=) Grade 2
- Evidence of Gilbert's Syndrome or homozygosity for the Uridine 5-diphospho-glucuronosyltransferase (UGT) 1A1*28 allele
- Positive for human immunodeficiency virus (HIV) infection
- Malignancies other than metastatic colorectal cancer 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 significant third-space fluid collections (e.g. ascites or pleural effusion) 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
- Any disease or condition or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of bevacizumab or puts the participant at high risk for treatment-related complications
- Inadequately controlled hypertension
- Clinically significant (that is [i.e.] active) cardiovascular disease (For example [e.g.] cerebrovascular accident or myocardial infarction within 6 months prior to randomization), unstable angina, congestive heart failure (New York Heart Association Class >/= II) or serious cardiac arrhythmia that is uncontrolled by medication or may interfere with the administration of the study treatment
- Known hypersensitivity to bevacizumab or any of its excipients or any other study drug
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Arm A: Concurrent FOLFOXIRI + Bevacizumab
Participants will receive concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase.
Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
|
Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion.
Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion.
Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression.
Ostatní jména:
Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase.
Ostatní jména:
Participants will receive IV infusion of 165 mg/m^2 over 1 hour every 2 weeks (Arm A) or IV infusion of 180 mg/m^2 over 1 hour in 2 x 2 weeks cycles alternating months (in Arm B), during 4-6 months induction phase.
Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy.
Ostatní jména:
Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase .
|
Experimentální: Arm B: Sequential FOLFOXIRI + Bevacizumab
Participants will receive alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase.
Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
|
Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion.
Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion.
Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression.
Ostatní jména:
Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase.
Ostatní jména:
Participants will receive IV infusion of 165 mg/m^2 over 1 hour every 2 weeks (Arm A) or IV infusion of 180 mg/m^2 over 1 hour in 2 x 2 weeks cycles alternating months (in Arm B), during 4-6 months induction phase.
Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy.
Ostatní jména:
Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase .
|
Experimentální: Arm C: FOLFOX + Bevacizumab
Participants will receive FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibit good response and tolerate the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase.
Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) will be administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion.
|
Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion.
Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion.
Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression.
Ostatní jména:
Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase.
Ostatní jména:
Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy.
Ostatní jména:
Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase .
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Percentage of Participants With Overall Response During First-Line Therapy (ORR1)
Časové okno: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
|
ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1).
CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis.
PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters.
ORR1 = CR + PR
|
Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
|
Progression-Free Survival During First-Line Therapy (PFS1)
Časové okno: Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
|
PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.
Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study.
The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm.
|
Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Time to PFS2
Časové okno: Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)
|
Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first.
Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study.
The sum of longest diameters must also demonstrate an absolute increase of at least 5mm.
|
Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)
|
Overall Survival (OS)
Časové okno: Randomization until death due to any cause (up to approximately 3 years)
|
OS was defined as the time from the date of randomization to the date of death from any cause.
|
Randomization until death due to any cause (up to approximately 3 years)
|
Proportion of Participants Who Underwent Liver Metastases Resections
Časové okno: Randomization up to approximately 3 years
|
Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm.
|
Randomization up to approximately 3 years
|
Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases
Časové okno: Randomization up to approximately 3 years
|
The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm.
This outcome represents a measure of the rate of conversion from unresectable to resectable disease.
|
Randomization up to approximately 3 years
|
Percentage of Participants With Adverse Events
Časové okno: Randomization up to approximately 3 years
|
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
|
Randomization up to approximately 3 years
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Cremolini C, Antoniotti C, Stein A, Bendell J, Gruenberger T, Rossini D, Masi G, Ongaro E, Hurwitz H, Falcone A, Schmoll HJ, Di Maio M. Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer. J Clin Oncol. 2020 Aug 20:JCO2001225. doi: 10.1200/JCO.20.01225. Online ahead of print.
- Hurwitz HI, Tan BR, Reeves JA, Xiong H, Somer B, Lenz HJ, Hochster HS, Scappaticci F, Palma JF, Price R, Lee JJ, Nicholas A, Sommer N, Bendell J. Phase II Randomized Trial of Sequential or Concurrent FOLFOXIRI-Bevacizumab Versus FOLFOX-Bevacizumab for Metastatic Colorectal Cancer (STEAM). Oncologist. 2019 Jul;24(7):921-932. doi: 10.1634/theoncologist.2018-0344. Epub 2018 Dec 14.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
23. ledna 2013
Primární dokončení (Aktuální)
14. března 2016
Dokončení studie (Aktuální)
14. března 2016
Termíny zápisu do studia
První předloženo
9. ledna 2013
První předloženo, které splnilo kritéria kontroly kvality
9. ledna 2013
První zveřejněno (Odhad)
10. ledna 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. září 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. srpna 2017
Naposledy ověřeno
1. srpna 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary
- Novotvary podle místa
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Onemocnění tlustého střeva
- Střevní nemoci
- Střevní novotvary
- Rektální onemocnění
- Kolorektální novotvary
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Ochranné prostředky
- Inhibitory topoizomerázy
- Antineoplastická činidla, Imunologická
- Inhibitory angiogeneze
- Činidla modulující angiogenezi
- Růstové látky
- Inhibitory růstu
- Mikroživiny
- Vitamíny
- Inhibitory topoizomerázy I
- Protijedy
- Vitamín B komplex
- Hematinika
- Fluorouracil
- Kapecitabin
- Oxaliplatina
- Bevacizumab
- Leukovorin
- Irinotekan
- Levoleukovorin
- Kyselina listová
Další identifikační čísla studie
- ML28442
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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