RANDOMIZED MULTICENTER PHASE III STUDY IN PATIENTS WITH LOCALLY ADVANCED ADENOCARCINOMA OF THE PANCREAS: GEMCITABINE WITH OR WITHOUT CHEMORADIOTHERAPY AND WITH OR WITHOUT ERLOTINIB - GERCOR - LAP 07
Phase 1
- Conditions
- ocally advanced, non-resectable, non-metastatic cancer of the pancreas
- Registration Number
- EUCTR2007-001174-81-SE
- Lead Sponsor
- GOF pancreatic cancer collaborative group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 442
Inclusion Criteria
Histologically approven adenocarcinoma of the pancreas.
Locally advanced non-resectable tumour.
Measurable or evaluable disease (RECIST).
No prior radiotherapy nor chemotherapy.
Performance status 0 - 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Resectable or metastatic cancer.
Periampullar cancer.
Other cancer within five years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether administrating a chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared to continue the same CT.;Secondary Objective: - To assess whether erlotinib combined with gemcitabine and administered as maintenance treatment increases progression free survival compared to gemcitabine alone and without maintenance.<br>- To evaluate the response rate in the CT and CRT arms.<br>- To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT.<br>;Primary end point(s): Improved survival.
- Secondary Outcome Measures
Name Time Method