RANDOMIZED MULTICENTER PHASE III STUDY IN PATIENTS WITH LOCALLY ADVANCED ADENOCARCINOMA OF THE PANCREAS: GEMCITABINE WITH OR WITHOUT CHEMORADIOTHERAPY AND WITH OR WITHOUT ERLOTINIB - LAP 07

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 902

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 2002 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

1. Localized cancer stage IA to IIB or metastatic cancer (stage IV) according to UICC 2002
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
15. Ampulloma and carcinoma of the periampullary region

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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