A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
NCT ID: NCT00865189
Last Updated: 2017-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2007-10-23
2016-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)
In this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous \[IV\] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
Oxaliplatin
Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m\^2) as a 2-hour IV infusion.
Folinic Acid
Folinic acid will be administered at a dose of 200 mg/m\^2 as a 2-hour infusion.
5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m\^2 as an IV bolus, then at a dose of 600 mg/m\^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m\^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
Surgery
Radical rectal excision based on the TME technique.
Arm B (Bevacizumab, Chemoradiotherapy)
In this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique.
Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m\^2 as an IV bolus, then at a dose of 600 mg/m\^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m\^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
Surgery
Radical rectal excision based on the TME technique.
Interventions
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Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
Oxaliplatin
Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m\^2) as a 2-hour IV infusion.
Folinic Acid
Folinic acid will be administered at a dose of 200 mg/m\^2 as a 2-hour infusion.
5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m\^2 as an IV bolus, then at a dose of 600 mg/m\^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m\^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
Surgery
Radical rectal excision based on the TME technique.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* measurable disease;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Exclusion Criteria
* prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
* previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
* history or evidence of central nervous system (CNS) disease;
* clinically significant cardiovascular disease;
* chronic treatment with high dose aspirin (more than \[\>\] 325 milligrams per day \[mg/day\]) or non-steroidal anti-inflammatory drugs.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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ICO Paul Papin; Oncologie Medicale.
Angers, , France
Angers, , France
HOPITAL JEAN MINJOZ; Oncologie
Besançon, , France
Besançon, , France
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
Bordeaux, , France
Bordeaux, , France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, , France
Dijon, , France
Hopital Albert Michallon; Radiotherapie
La Tronche, , France
La Tronche, , France
Centre Oscar Lambret; Radiotherapie
Lille, , France
Lille, , France
Centre Hospitalier Andre Boulloche; Departement D'Oncologie
Montbéliard, , France
Montbéliard, , France
Centre Val Aurelle Paul Lamarque; Radiotherapie
Montpellier, , France
Montpellier, , France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, , France
Nancy, , France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, , France
Nice, , France
Hopital Saint Louis; Radiotherapie Oncologie
Paris, , France
Paris, , France
Ch Pitie Salpetriere; Oncologie Medicale
Paris, , France
Paris, , France
HOPITAL TENON; Cancerologie Medicale
Paris, , France
Paris, , France
Ch Lyon Sud; Radiotherapie Sct Jules Courmont
Pierre-Bénite, , France
Pierre-Bénite, , France
Chu La Miletrie; Radiotherapie
Poitiers, , France
Poitiers, , France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, , France
Saint-Herblain, , France
Centre Paul Strauss; Oncologie Medicale
Strasbourg, , France
Strasbourg, , France
Polyclinique Du Parc; Centre De Hautes Energies
Toulouse, , France
Toulouse, , France
Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
Tours, , France
Tours, , France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, , France
Vandœuvre-lès-Nancy, , France
Countries
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References
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Borg C, Andre T, Mantion G, Boudghene F, Mornex F, Maingon P, Adenis A, Azria D, Piutti M, Morsli O, Bosset JF. Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer: a randomized, noncomparative phase II study. Ann Oncol. 2014 Nov;25(11):2205-2210. doi: 10.1093/annonc/mdu377. Epub 2014 Aug 13.
Other Identifiers
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2006-003472-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML19202
Identifier Type: -
Identifier Source: org_study_id
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