Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic Cancer (PACT-15)
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically* confirmed adenocarcinoma of pancreas
- Stage I-II disease
- Resectable disease
- No superior mesenteric vein or artery, portal vein, celiac trunk, or hepatic artery infiltration
- No symptomatic duodenal stenosis
- NOTE: Patients without histological or cytological results may be allowed provided ≥ 1 attempt has been made by needle aspiration with negative imaging and clinical signs suggestive of adenocarcinoma.
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- WBC ≥ 3,500/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.5 mg/dL
- ALT and AST ≤ 3 times upper limit of normal
- Bilirubin ≤ 3 mg/dL
- No prior or concurrent malignancy within the past 5 years except for surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- Not pregnant or nursing
- No psychological, familial, sociological, or geographical condition that would potentially hinder study compliance or follow-up schedule
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
- No other concurrent experimental drugs
Sites / Locations
- Istituto Scientifico H. San Raffaele
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
adjuvant PEXG
perioperative PEXG
Adjuvant Gemcitabine
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 6 months
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 3 months before surgery and 3 months after surgery
Adjuvant Gemcitabine at 1000 mg/mq for 3 weeks every 4 weeks for 6 months