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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00865189
First received: March 18, 2009
Last updated: November 24, 2014
Last verified: November 2014

March 18, 2009
November 24, 2014
November 2007
March 2016   (final data collection date for primary outcome measure)
Rate of sterilisation of tumoral specimen: YpT0-N0 [ Time Frame: After surgery (6-8 weeks after chemoradiation) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865189 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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) Safety:at each clinic visit throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Patients With Newly Diagnosed Locally Advanced Rectal Cancer.
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

This study will assess the efficacy and safety of two different neoadjuvant trea tment approaches including Avastin in newly diagnosed patients with high risk lo cally advanced rectal cancer. Patients will be randomized into one of two treatm ent arms. Arm A will undergo an induction phase, consisting of 6 cycles of Avast in (5mg/kg iv) plus FOLFOX 4, followed by a 7 week chemoradiation phase, consist ing 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 foll owed by surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    6x2 week cycles of 5mg/kg iv + FOLFOX, followed by 4x2 week cycles of 5mg/kg iv + 5-FU + radiotherapy
  • Drug: bevacizumab [Avastin]
    4 x 2 week cycles of 5mg/kg iv + 5-FU + radiotherapy
  • Experimental: 1
    Intervention: Drug: bevacizumab [Avastin]
  • Experimental: 2
    Intervention: Drug: bevacizumab [Avastin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
91
March 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00865189
ML19202
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP