Status:
COMPLETED
Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic Cancer
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, and capecitabine, work in different ways to stop the growth of tumor cells, either by kil...
Detailed Description
OBJECTIVES: Primary * To assess the proportion of patients who are event-free (defined as disease progression, local recurrence, distant metastasis, new tumor, or death) at 1 year after neoadjuvant ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01150630
Start Date
May 1 2010
End Date
August 1 2017
Last Update
September 1 2017
Active Locations (1)
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1
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132