A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
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.
1 other identifier
interventional
43
1 country
9
Brief Summary
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 colorectal-cancer
Started Nov 2005
Typical duration for phase_2 colorectal-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedAugust 17, 2015
July 1, 2015
4.8 years
October 22, 2010
May 28, 2014
July 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Pathological Complete Response (pCR)
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
6 to 8 weeks following completion of neoadjuvant treatment
Secondary Outcomes (12)
Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)
Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)
Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
6 to 8 weeks after completion of study treatment
Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment
BL and within 6 weeks after the completion of study treatment
Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment
BL and within 6 weeks after the completion of study treatment
Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment
BL and within 6 weeks after the completion of study treatment
- +7 more secondary outcomes
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months
Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Ancona, 60121, Italy
Unknown Facility
Bologna, 40139, Italy
Unknown Facility
Cuneo, 12100, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Napoli, 80131, Italy
Unknown Facility
Paola, 87027, Italy
Unknown Facility
Pisa, 56100, Italy
Unknown Facility
Roma, 00135, Italy
Unknown Facility
Siena, 53100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 25, 2010
Study Start
November 1, 2005
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 17, 2015
Results First Posted
August 15, 2014
Record last verified: 2015-07