Patients with de novo locally advanced, histologically proven adenocarcinoma of the pancreas without distant metastases (stage III according to the UICC classification) and not considered for curative resection after pluridisciplinary discussion. MedDRA version: 9.1 Level: LLT Classification code 10052747 Term: Adenocarcinoma pancreas
Conditions
Interventions
Trade Name: TARCEVA
Pharmaceutical Form: Tablet
Trade Name: XELODA
Pharmaceutical Form: Tablet
Sponsors
GERCOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age older than = 18 2. Patients with de novo locally advanced, histologically proven adenocarcinoma of the pancreas without distant metastases (stage III according to the UICC classification) and not considered for curative resection after pluridisciplinary discussion. 3. ECOG Performance Status = 2 4. Estimated life expectancy = 12 weeks 5. No prior radiotherapy nor chemotherapy for any reason 6. Signed informed consent form 7. Polynuclear neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and hemoglobin = 9 g/dL 8. Total bilirubin =1.5 N (N: upper limit of normal). In patients who have had a recent biliary drain and whose bilirubin is descending, a value of = 3 N (50 µmoles/L) is acceptable. 9. AST and ALT = 2.5 N, alkaline phosphatase = 5 N 10. Albumin = 25 g/L 11. Creatinin = 177 µmol/L (2 mg/dL) 12. Female patients who are not menopausal and their partners must accept to use effective contraception throughout treatment and for 3 months after the end of treatment. All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator. 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
Exclusion criteria: 1. Localized stage IA to IIB or metastatic cancer (stage IV) according to UICC 2. Previous chemotherapy for any reason 3. Previous abdominal radiotherapy 4. Allergy to one of ingredients in erlotinib 5. Prior treatment with an anti-EGFR 6. Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the uterus or basal cell skin cancer. 7. Severe infection 8. Ophthalmic disease (inflammation, keratopathy or infection) 9. Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the last 6 months. 10. Unable to take oral treatments or with gastrointestinal disorders that could be associated with absorption disorders, untreated gastric or duodenal ulcer. 11. Pregnancy or breast feeding 12. Unable to follow for psychological, familial or geographic reasons. 13. Not affiliated with a social security regime. 14. Diarrhea = grade 2 and/or uncontrolled diarrhoea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To evaluate the response rate in the CT and CRT arms. - To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT. ;Primary end point(s): 1. Overall survival Survival will be assessed from the date of the first randomization to the date of patient death, due to any cause, or to the last date the patient was known to be alive. Patients who were not reported as having died at the time of the analysis will be censored using the date they were last known to be alive. 2. Progression Free Survival Progression-free survival (PFS) is the time from the date of the first randomization to the date of progressive disease (RECIST criteria) or death. Death will be regarded as a progression event in those patients who die before disease progression. Patients without documented objective progression at the time of the final analysis will be censored at the date of their last objective tumor assessment. 3. Definition of Response The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria will be used for this trial for objective tumor response assessment. | — |
Countries
Belgium, France, Sweden
Outcome results
None listed