A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma
18 Years
N/A
Both
Pancreatic Neoplasms
Trial Information
A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma
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
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:
To evaluate recurrence free one year survival, time to disease progression and local recurrence rate, analyzed at the end of the study
Principal Investigator
1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
6866
NCT ID:
NCT00191568
Start Date:
October 2002
Completion Date:
May 2007
Related Keywords:
- Pancreatic Neoplasms
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|
