Gemcitabine, Oxaliplatin and Radiotherapy in Treating Patients With Completely Resected Pancreatic Cancer
Phase 2
Completed
- Conditions
- Pancreatic Neoplasms
- Registration Number
- NCT00191568
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Pathologically confirmed adenocarcinoma of the pancreas
- Patient have undergone a potentially curative resection
- No previous irradiation to the planned field
- Negative pregnancy test for child bearing women
Exclusion Criteria
- Non-adenocarcinoma pancreatic cancer
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious systemic disorder
- Metastatic disease
- Pregnancy, breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study
- Secondary Outcome Measures
Name Time Method To assess overall survival at the end of the 24 months follow up period;To assess acute and late toxicity (every month for the first 3 months and then every three months for 24 months after treatment discontinuation)
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) MON-FRI 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
🇫🇷Pierre Benite, France