- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01765582
Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer (STEAM)
18. August 2017 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
280
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Alabama
-
Mobile, Alabama, Vereinigte Staaten, 36604
- University of South Alabama; Mitchell Cancer Institute
-
-
California
-
Long Beach, California, Vereinigte Staaten, 90806
- Long Beach Memorial Medical Center; Oncology
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Los Angeles, California, Vereinigte Staaten, 90033
- USC Norris Cancer Center
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Los Angeles, California, Vereinigte Staaten, 90033
- LAC-USC Medical Center
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Monterey, California, Vereinigte Staaten, 93940
- Pacific Cancer Care - Monterey
-
Sacramento, California, Vereinigte Staaten, 95816
- Sacramento Center for Hematolo
-
Salinas, California, Vereinigte Staaten, 93901
- Pacific Cancer Care
-
-
Colorado
-
Denver, Colorado, Vereinigte Staaten, 80205
- Kaiser Permanente - Franklin
-
-
Connecticut
-
New Haven, Connecticut, Vereinigte Staaten, 06520
- Yale Cancer Center
-
-
District of Columbia
-
Washington, D.C., District of Columbia, Vereinigte Staaten, 20016
- Sibley Memorial Hospital
-
-
Florida
-
Fort Myers, Florida, Vereinigte Staaten, 33905
- Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
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Saint Petersburg, Florida, Vereinigte Staaten, 33705
- Florida Cancer Specialist, North Region
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-
Georgia
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Athens, Georgia, Vereinigte Staaten, 30607
- University Cancer & Blood Center, LLC
-
Atlanta, Georgia, Vereinigte Staaten, 30322
- Emory University Clinic
-
Macon, Georgia, Vereinigte Staaten, 31201
- Central Georgia Cancer Care PC
-
Savannah, Georgia, Vereinigte Staaten, 31405
- Summit Cancer Care PC
-
-
Illinois
-
Harvey, Illinois, Vereinigte Staaten, 60426
- Ingalls Memorial Hosp
-
Naperville, Illinois, Vereinigte Staaten, 60540
- Edward Cancer Center Naperville
-
Plainfield, Illinois, Vereinigte Staaten, 60585
- Edward Cancer Center Plainfield
-
-
Kentucky
-
Lexington, Kentucky, Vereinigte Staaten, 40536
- University of Kentucky Medical Center
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21231
- Johns Hopkins Univ; Bunting Blaustein Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02111
- Tufts Medical Center
-
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48106
- St. Joseph Mercy Hospital; Cancer Care Center.
-
Detroit, Michigan, Vereinigte Staaten, 48201
- Karmanos Cancer Institute..
-
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Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
-
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Nebraska
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Lincoln, Nebraska, Vereinigte Staaten, 68510
- Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
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Omaha, Nebraska, Vereinigte Staaten, 68114
- Nebraska Methodist Hospital; Cancer Center
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Dartmouth Hitchcock Med Center
-
-
Ohio
-
Cincinnati, Ohio, Vereinigte Staaten, 45242
- Oncology Hematology Care Inc
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- University of Oklahoma; Stephenson Oklahoma Canc Ctr
-
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Pennsylvania
-
Hershey, Pennsylvania, Vereinigte Staaten, 17033
- Milton S. Hershey Medical Center; Penn State Cancer Inst.
-
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Tennessee
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Chattanooga, Tennessee, Vereinigte Staaten, 37404
- Chattanooga Oncology and Hematology Associates, PC
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Germantown, Tennessee, Vereinigte Staaten, 38138
- West Clinic
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Sarah Cannon Cancer Center and Research Institute
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Texas
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Dallas, Texas, Vereinigte Staaten, 75390-9063
- UT Southwestern MC at Dallas
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Fort Worth, Texas, Vereinigte Staaten, 76104
- Ctr For Cancer And Blood Disorders
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Temple, Texas, Vereinigte Staaten, 76508
- Scott and White Hospital; Cancer Center
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Virginia
-
Richmond, Virginia, Vereinigte Staaten, 23226
- Virginia Cancer Institute
-
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Washington
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Kirkland, Washington, Vereinigte Staaten, 98034
- Seattle Cancer Care Alliance - Evergreen Health
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Seattle, Washington, Vereinigte Staaten, 98109
- Seattle Cancer Care Alliance
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Spokane, Washington, Vereinigte Staaten, 99208
- Medical Oncology Associates
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Wisconsin
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Green Bay, Wisconsin, Vereinigte Staaten, 54311
- Vince Lombardi Cancer Center
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Medical College of Wisconsin; Dept Froedtert Clin Can Ctr
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Wauwatosa, Wisconsin, Vereinigte Staaten, 53226
- Aurora Research Institute
-
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Wyoming
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Cheyenne, Wyoming, Vereinigte Staaten, 82001
- Cheyenne Oncology & Hematology Associates
-
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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 .
|
Experimental: 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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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 .
|
Experimental: 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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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 .
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants With Overall Response During First-Line Therapy (ORR1)
Zeitfenster: 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)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to PFS2
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
23. Januar 2013
Primärer Abschluss (Tatsächlich)
14. März 2016
Studienabschluss (Tatsächlich)
14. März 2016
Studienanmeldedaten
Zuerst eingereicht
9. Januar 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Januar 2013
Zuerst gepostet (Schätzen)
10. Januar 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. September 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. August 2017
Zuletzt verifiziert
1. August 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Kolorektale Neubildungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Schutzmittel
- Topoisomerase-Inhibitoren
- Antineoplastische Mittel, immunologische
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Mikronährstoffe
- Vitamine
- Topoisomerase I-Inhibitoren
- Gegenmittel
- Vitamin B-Komplex
- Hämatitik
- Fluorouracil
- Capecitabin
- Oxaliplatin
- Bevacizumab
- Leucovorin
- Irinotecan
- Levoleucovorin
- Folsäure
Andere Studien-ID-Nummern
- ML28442
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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