- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01227707
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
July 21, 2015 updated by: Hoffmann-La Roche
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.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ancona, Italy, 60121
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Bologna, Italy, 40139
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Cuneo, Italy, 12100
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Genova, Italy, 16132
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Napoli, Italy, 80131
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Paola, Italy, 87027
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Pisa, Italy, 56100
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Roma, Italy, 00135
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Siena, Italy, 53100
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
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5 mg/kg intravenously every 2 weeks, 4 cycles
825 mg/m2 twice daily orally, 38 days
Total dose of 45 Gy over 38 days
6-8 weeks after completion of neoadjuvant treatment
Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Pathological Complete Response (pCR)
Time Frame: 6 to 8 weeks following completion of neoadjuvant treatment
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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.
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6 to 8 weeks following completion of neoadjuvant treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)
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The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed.
The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated.
The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI).
Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.
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Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)
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Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure
Time Frame: 6 to 8 weeks after completion of study treatment
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6 to 8 weeks after completion of study treatment
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Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment
Time Frame: BL and within 6 weeks after the completion of study treatment
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Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST).
CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.
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BL and within 6 weeks after the completion of study treatment
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Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment
Time Frame: BL and within 6 weeks after the completion of study treatment
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Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST.
CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.
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BL and within 6 weeks after the completion of study treatment
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Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment
Time Frame: BL and within 6 weeks after the completion of study treatment
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The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.
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BL and within 6 weeks after the completion of study treatment
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Percentage of Participants With Relapse During Follow-Up
Time Frame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
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The percentage of participants with local and/or regional relapse during follow-up.
New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.
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BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
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Disease-Free Survival (DFS) - Percentage of Participants With an Event
Time Frame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
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DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.
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BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
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DFS - Time to Event
Time Frame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
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The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause.
If a participant did not have an event, the time was censored at the date of last adequate tumor assessment.
DFS was estimated using the Kaplan-Meier method.
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BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months
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Overall Survival (OS) - Percentage of Participants With an Event
Time Frame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
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OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.
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BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
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OS - Time to Event
Time Frame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
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OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.
OS was estimated using the Kaplan-Meier method.
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BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
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Time to Disease Progression (TTP) - Percentage of Participants With an Event
Time Frame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
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TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.
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BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
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TTP - Time to Event
Time Frame: BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
|
TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.
TTP was estimated using the Kaplan-Meier method.
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BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
October 22, 2010
First Submitted That Met QC Criteria
October 22, 2010
First Posted (Estimate)
October 25, 2010
Study Record Updates
Last Update Posted (Estimate)
August 17, 2015
Last Update Submitted That Met QC Criteria
July 21, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Capecitabine
- Bevacizumab
- Leucovorin
Other Study ID Numbers
- ML18522
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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