A phase II study to evaluate the efficacy of bevacizumab in combination with capecitabine and concomitant radiotherapy in patients affected by non-resectable locally advanced pancreatic cancer. - GP06
- Conditions
- ocally advanced pancreatic cancer.MedDRA version: 9.1Level: LLTClassification code 10033611Term: Pancreatic carcinoma non-resectable
- Registration Number
- EUCTR2006-002992-42-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-Age 18-75;
-Zubrod Performance status 0-1;
-Histologically confirmed locally advanced pancreatic cancer.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Brain or visceral metastasis;
-Prior radiotherapy or chemotherapy within 5 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the overall survival after 1 year of treatment with bevacizumab in combination with capecitabine and concomitant radiotherapy in patients affected by non-resectable locally advanced pancreatic cancer.;Secondary Objective: -To evaluate the incidence of serious adverse events during treatment;<br><br>-To assess the objective response rate of this regimen;<br><br>-To evaluate the failure free survival (FFS) after 1 year of treatment;<br><br>-To assess the number of patient who undergo surgery after treament.;Primary end point(s): Overall survival.
- Secondary Outcome Measures
Name Time Method