Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer (STEAM)
2017. augusztus 18. frissítette: 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.
A tanulmány áttekintése
Állapot
Megszűnt
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
280
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
Alabama
-
Mobile, Alabama, Egyesült Államok, 36604
- University of South Alabama; Mitchell Cancer Institute
-
-
California
-
Long Beach, California, Egyesült Államok, 90806
- Long Beach Memorial Medical Center; Oncology
-
Los Angeles, California, Egyesült Államok, 90033
- USC Norris Cancer Center
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Los Angeles, California, Egyesült Államok, 90033
- LAC-USC Medical Center
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Monterey, California, Egyesült Államok, 93940
- Pacific Cancer Care - Monterey
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Sacramento, California, Egyesült Államok, 95816
- Sacramento Center for Hematolo
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Salinas, California, Egyesült Államok, 93901
- Pacific Cancer Care
-
-
Colorado
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Denver, Colorado, Egyesült Államok, 80205
- Kaiser Permanente - Franklin
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-
Connecticut
-
New Haven, Connecticut, Egyesült Államok, 06520
- Yale Cancer Center
-
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District of Columbia
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Washington, D.C., District of Columbia, Egyesült Államok, 20016
- Sibley Memorial Hospital
-
-
Florida
-
Fort Myers, Florida, Egyesült Államok, 33905
- Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
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Saint Petersburg, Florida, Egyesült Államok, 33705
- Florida Cancer Specialist, North Region
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Georgia
-
Athens, Georgia, Egyesült Államok, 30607
- University Cancer & Blood Center, LLC
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Atlanta, Georgia, Egyesült Államok, 30322
- Emory University Clinic
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Macon, Georgia, Egyesült Államok, 31201
- Central Georgia Cancer Care PC
-
Savannah, Georgia, Egyesült Államok, 31405
- Summit Cancer Care PC
-
-
Illinois
-
Harvey, Illinois, Egyesült Államok, 60426
- Ingalls Memorial Hosp
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Naperville, Illinois, Egyesült Államok, 60540
- Edward Cancer Center Naperville
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Plainfield, Illinois, Egyesült Államok, 60585
- Edward Cancer Center Plainfield
-
-
Kentucky
-
Lexington, Kentucky, Egyesült Államok, 40536
- University of Kentucky Medical Center
-
-
Maryland
-
Baltimore, Maryland, Egyesült Államok, 21231
- Johns Hopkins Univ; Bunting Blaustein Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Egyesült Államok, 02111
- Tufts Medical Center
-
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Michigan
-
Ann Arbor, Michigan, Egyesült Államok, 48106
- St. Joseph Mercy Hospital; Cancer Care Center.
-
Detroit, Michigan, Egyesült Államok, 48201
- Karmanos Cancer Institute..
-
-
Missouri
-
Saint Louis, Missouri, Egyesült Államok, 63110
- Washington University School of Medicine
-
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Nebraska
-
Lincoln, Nebraska, Egyesült Államok, 68510
- Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
-
Omaha, Nebraska, Egyesült Államok, 68114
- Nebraska Methodist Hospital; Cancer Center
-
-
New Hampshire
-
Lebanon, New Hampshire, Egyesült Államok, 03756
- Dartmouth Hitchcock Med Center
-
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Ohio
-
Cincinnati, Ohio, Egyesült Államok, 45242
- Oncology Hematology Care Inc
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Egyesült Államok, 73104
- University of Oklahoma; Stephenson Oklahoma Canc Ctr
-
-
Pennsylvania
-
Hershey, Pennsylvania, Egyesült Államok, 17033
- Milton S. Hershey Medical Center; Penn State Cancer Inst.
-
-
Tennessee
-
Chattanooga, Tennessee, Egyesült Államok, 37404
- Chattanooga Oncology and Hematology Associates, PC
-
Germantown, Tennessee, Egyesült Államok, 38138
- West Clinic
-
Nashville, Tennessee, Egyesült Államok, 37203
- Sarah Cannon Cancer Center and Research Institute
-
-
Texas
-
Dallas, Texas, Egyesült Államok, 75390-9063
- UT Southwestern MC at Dallas
-
Fort Worth, Texas, Egyesült Államok, 76104
- Ctr For Cancer And Blood Disorders
-
Temple, Texas, Egyesült Államok, 76508
- Scott and White Hospital; Cancer Center
-
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Virginia
-
Richmond, Virginia, Egyesült Államok, 23226
- Virginia Cancer Institute
-
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Washington
-
Kirkland, Washington, Egyesült Államok, 98034
- Seattle Cancer Care Alliance - Evergreen Health
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Seattle, Washington, Egyesült Államok, 98109
- Seattle Cancer Care Alliance
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Spokane, Washington, Egyesült Államok, 99208
- Medical Oncology Associates
-
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Wisconsin
-
Green Bay, Wisconsin, Egyesült Államok, 54311
- Vince Lombardi Cancer Center
-
Milwaukee, Wisconsin, Egyesült Államok, 53226
- Medical College of Wisconsin; Dept Froedtert Clin Can Ctr
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Wauwatosa, Wisconsin, Egyesült Államok, 53226
- Aurora Research Institute
-
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Wyoming
-
Cheyenne, Wyoming, Egyesült Államok, 82001
- Cheyenne Oncology & Hematology Associates
-
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
Más nevek:
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.
Más nevek:
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.
Más nevek:
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 .
|
|
Kísérleti: 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.
Más nevek:
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.
Más nevek:
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.
Más nevek:
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 .
|
|
Kísérleti: 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.
Más nevek:
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.
Más nevek:
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.
Más nevek:
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 .
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Percentage of Participants With Overall Response During First-Line Therapy (ORR1)
Időkeret: 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)
Időkeret: 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)
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Time to PFS2
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2013. január 23.
Elsődleges befejezés (Tényleges)
2016. március 14.
A tanulmány befejezése (Tényleges)
2016. március 14.
Tanulmányi regisztráció dátumai
Először benyújtva
2013. január 9.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2013. január 9.
Első közzététel (Becslés)
2013. január 10.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2017. szeptember 18.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2017. augusztus 18.
Utolsó ellenőrzés
2017. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Emésztőrendszeri betegségek
- Neoplazmák
- Neoplazmák webhelyenként
- Gasztrointesztinális neoplazmák
- Emésztőrendszeri neoplazmák
- Emésztőrendszeri betegségek
- Vastagbélbetegségek
- Bélbetegségek
- Bél neoplazmák
- Rektális betegségek
- Kolorektális neoplazmák
- A gyógyszerek élettani hatásai
- A farmakológiai hatás molekuláris mechanizmusai
- Enzim gátlók
- Antimetabolitok, daganatellenes
- Antimetabolitok
- Antineoplasztikus szerek
- Immunszuppresszív szerek
- Immunológiai tényezők
- Védőszerek
- Topoizomeráz gátlók
- Immunológiai daganatellenes szerek
- Angiogenezis gátlók
- Angiogenezist moduláló szerek
- Növekedést elősegítő anyagok
- Növekedésgátlók
- Mikrotápanyagok
- Vitaminok
- Topoizomeráz I gátlók
- Ellenszerek
- B-vitamin komplex
- Hematinics
- Fluorouracil
- Kapecitabin
- Oxaliplatin
- Bevacizumab
- Leucovorin
- Irinotekán
- Levoleukovorin
- Folsav
Egyéb vizsgálati azonosító számok
- ML28442
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Igen
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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The Netherlands Cancer InstituteBefejezve
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Singapore National Eye CentreSingapore Eye Research Institute; Nanchang UniversityBefejezveGlaukóma | Sebgyógyulás | TrabeculectomiaSzingapúr
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)BefejezveColorectalis rák | Áttétes rákEgyesült Államok
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Peking Union Medical College HospitalToborzásVégbélrák | Vastagbél rák | Kemoterápiás hatás | PTC | Exon mutációKína
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National Cancer Institute (NCI)Toborzás
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UNC Lineberger Comprehensive Cancer CenterAktív, nem toborzóHIV fertőzések | CIN 2/3Kenya