An Open-label Study to Assess the Effect of Combination Treatment With Avastin and Xeloda, Plus Pre-operative Standard Radiotherapy, on Response Rate in Patients With Locally Advanced Rectal Cancer.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
An Open-label Study to Assess the Effect of Combination Treatment With Avastin and Xeloda, Plus Pre-operative Standard Radiotherapy, on Response Rate in Patients With Locally Advanced Rectal Cancer.
Inclusion Criteria:
- Adult patients, >=18 years of age
- Patients with confirmed rectal cancer who are subject to surgery and would benefit
from pre-operative combined chemo-radiotherapy
- Measurable and/or evaluable lesions according to RECIST criteria
- EOCG performance status 0-1
Exclusion Criteria:
- Prior radiotherapy or chemotherapy for rectal cancer
- Untreated brain metastases or spinal cord compression or primary brain tumors
- Chronic daily treatment with high-dose aspirin (>325 mg/day) or other medications
known to predispose to gastrointestinal ulceration
- Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the
exception of basal and squamous cell cancer, or cervical cancer in situ.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological complete response rate (pCR) after chemo-radiotherapy (histologic tumour assessment by local and central pathologist)
Outcome Time Frame:
approximately 2 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML18522
NCT ID:
NCT01227707
Start Date:
November 2005
Completion Date:
August 2010
Related Keywords:
- Colorectal Cancer
- Rectal Neoplasms
- Colorectal Neoplasms
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