NCT00865189 - A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 23, 2007

Primary Completion Date

March 23, 2016

Study Completion Date

March 23, 2016

Conditions

Rectal Cancer

Interventions

DRUG

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.

DRUG

Oxaliplatin

Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m\^2) as a 2-hour IV infusion.

DRUG

Folinic Acid

Folinic acid will be administered at a dose of 200 mg/m\^2 as a 2-hour infusion.

DRUG

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.

RADIATION

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.

PROCEDURE

Surgery

Radical rectal excision based on the TME technique.

Trial Locations (40)

21079

Centre Georges Francois Leclerc; Oncologie 3, Dijon

Dijon

25030

HOPITAL JEAN MINJOZ; Oncologie, Besançon

Besançon

25209

Centre Hospitalier Andre Boulloche; Departement D'Oncologie, Montbéliard

Montbéliard

31078

Polyclinique Du Parc; Centre De Hautes Energies, Toulouse

Toulouse

33075

Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale, Bordeaux

Bordeaux

34928

Centre Val Aurelle Paul Lamarque; Radiotherapie, Montpellier

Montpellier

37044

Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie, Tours

Tours

38700

Hopital Albert Michallon; Radiotherapie, La Tronche

La Tronche

44805

Ico Rene Gauducheau; Oncologie, Saint-Herblain

Saint-Herblain

49055

ICO Paul Papin; Oncologie Medicale., Angers

Angers

54100

Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE, Nancy

Nancy

54511

Centre Alexis Vautrin; Oncologie Medicale, Vandœuvre-lès-Nancy

Vandœuvre-lès-Nancy

59020

Centre Oscar Lambret; Radiotherapie, Lille

Lille

67065

Centre Paul Strauss; Oncologie Medicale, Strasbourg

Strasbourg

69495

Ch Lyon Sud; Radiotherapie Sct Jules Courmont, Pierre-Bénite

Pierre-Bénite

75475

Hopital Saint Louis; Radiotherapie Oncologie, Paris

Paris

75651

Ch Pitie Salpetriere; Oncologie Medicale, Paris

Paris

75970

HOPITAL TENON; Cancerologie Medicale, Paris

Paris

86021

Chu La Miletrie; Radiotherapie, Poitiers

Poitiers

06189

Centre Antoine Lacassagne; Hopital De Jour A2, Nice

Nice

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY