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A Study of Avastin (Bevacizumab) in Patients With Newly Diagnosed Locally Advanced Rectal Cancer.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: March 18, 2009
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Colorectal Cancer Drug: bevacizumab [Avastin] Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of sterilisation of tumoral specimen: YpT0-N0 [ Time Frame: After surgery (6-8 weeks after chemoradiation) ]

Secondary Outcome Measures:
  • Efficacy: Compliance, pathological tumor downstaging rate, recurrence rates, disease free survival, overall survival. Safety: AEs, SAEs, lab parameters, post-operative complications. [ Time Frame: Efficacy:event driven (throughout study)\nSafety:at each clinic visit throughout study ]

Enrollment: 91
Study Start Date: November 2007
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
6x2 week cycles of 5mg/kg iv + FOLFOX, followed by 4x2 week cycles of 5mg/kg iv + 5-FU + radiotherapy
Experimental: 2 Drug: bevacizumab [Avastin]
4 x 2 week cycles of 5mg/kg iv + 5-FU + radiotherapy


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00865189

Angers, France, 49055
Besancon, France, 25030
Bordeaux, France, 33075
Dijon, France, 21079
La Tronche, France, 38700
Lille, France, 59020
Montbeliard, France, 25209
Montpellier, France, 34928
Nancy, France, 54100
Nice, France, 06189
Paris, France, 75475
Paris, France, 75651
Paris, France, 75970
Pierre Benite, France, 69495
Poitiers, France, 86021
Saint Herblain, France, 44805
Strasbourg, France, 67065
Toulouse, France, 31078
Tours, France, 37044
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00865189     History of Changes
Other Study ID Numbers: ML19202
Study First Received: March 18, 2009
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on June 27, 2017