Trial information
A Study of Avastin (Bevacizumab) in Patients With Newly Diagnosed Locally Advanced Rectal Cancer.
Status: Recruiting
Protocol number: ML19202
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to assess the effect on tumor response, and the safety, of two neo-adjuvant approaches with Avastin in newly-diagnosed patients with high risk locally-advanced rectal cancer
Brief summary: This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including Avastin in newly diagnosed patients with high risk locally advanced rectal cancer. Patients will be randomized into one of two treatment arms. Arm A will undergo an induction phase, consisting of 6 cycles of Avastin (5mg/kg iv) plus FOLFOX 4, followed by a 7 week chemoradiation phase, consisting of Avastin (5mg/kg iv) plus 5-FU plus radiotherapy, followed by surgery. Arm B will omit the induction phase, but will undergo the chemoradiation phase followed by surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 91.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Rate of sterilisation of tumoral specimen: YpT0-N0
Key secondary outcomes: 1. Efficacy: Compliance, pathological tumor downstaging rate, recurrence rates, disease free survival, overall survival. Safety: AEs, SAEs, lab parameters, post-operative complications.
Inclusion criteria:
- adult patients, 18-75 years of age;
- histologically confirmed locally advanced rectal cancer;
- measurable disease;
- ECOG performance status 0-1;
- no prior chemotherapy or radiation therapy for rectal cancer.
Exclusion criteria:
- prior treatment with Avastin;
- 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 CNS disease;
- clinically significant cardiovascular disease;
- chronic treatment with high dose aspirin (>325mg/day) or NSAID.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: October, 2007
Trial registration date: 11/16/2006
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Angers
- Annecy
- Avignon
- Besancon
- Bordeaux
- Dijon
- La Tronche
- Lille
- Montbeliard
- Montpellier
- Nancy
- Nice
- Paris
- Pierre Benite
- Poitiers
- Saint Herblain
- Saint Priest En Jarez
- Strasbourg
- Toulouse
- Tours
- Vandoeuvre-Les-Nancy
- Villejuif
