Clinical trial NCT00865189: A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
Official title: Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).


Eligibility criteria: Inclusion Criteria:

* histologically confirmed locally advanced rectal cancer;
* measurable disease;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

* prior treatment with bevacizumab;
* 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.

Primary outcomes:
measure: Percentage of Participants With Tumor Sterilization Defined by ypT0-N0
timeFrame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Secondary outcomes:
measure: Percentage of Participants With Tumor Down-Staging (ypT0-pT2)
timeFrame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
measure: Percentage of Participants With Local and Distant Recurrences
timeFrame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
measure: Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death
timeFrame: Baseline up to approximately 6 years
measure: Disease-Free Survival (DFS)
timeFrame: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
measure: Percentage of Participants Who Died
timeFrame: Baseline up to approximately 6 years
measure: Overall Survival
timeFrame: From the first treatment administration to the date of death (up to approximately 6 years)
measure: Number of Cycles of Induction Chemotherapy
timeFrame: 6 cycles (12 weeks; cycle length = 14 days)
measure: Number of Cycles of Chemotherapy
timeFrame: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
measure: Number of Cycles of Radiotherapy
timeFrame: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
measure: Percentage of Participants With Surgery
timeFrame: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO Paul Papin; Oncologie Medicale.
city: Angers
country: France
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Besancon
country: France
city: Bordeaux
country: France
facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
city: Bordeaux
country: France
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Dijon
country: France
city: La Tronche
country: France
facility: Hopital Albert Michallon; Radiotherapie
city: La Tronche
country: France
city: Lille
country: France
facility: Centre Oscar Lambret; Radiotherapie
city: Lille
country: France
city: Montbeliard
country: France
facility: Centre Hospitalier Andre Boulloche; Departement D'Oncologie
city: Montbeliard
country: France
city: Montpellier
country: France
facility: Centre Val Aurelle Paul Lamarque; Radiotherapie
city: Montpellier
country: France
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Nancy
country: France
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Nice
country: France
city: Paris
country: France
facility: Hopital Saint Louis; Radiotherapie Oncologie
city: Paris
country: France
city: Paris
country: France
facility: Ch Pitie Salpetriere; Oncologie Medicale
city: Paris
country: France
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Paris
country: France
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Radiotherapie Sct Jules Courmont
city: Pierre Benite
country: France
city: Poitiers
country: France
facility: Chu La Miletrie; Radiotherapie
city: Poitiers
country: France
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau; Oncologie
city: Saint Herblain
country: France
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Strasbourg
country: France
city: Toulouse
country: France
facility: Polyclinique Du Parc; Centre De Hautes Energies
city: Toulouse
country: France
city: Tours
country: France
facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
city: Tours
country: France
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Vandoeuvre Les Nancy
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: 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.