Status:
COMPLETED
Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic Cancer
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells,...
Detailed Description
OBJECTIVES: Primary * Assess the 1-year progression-free survival of patients with stage IB, II, or III adenocarcinoma of the pancreas treated with adjuvant therapy comprising gemcitabine with vs wi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas
- Stage IB-III disease
- Has undergone surgery with radical intent (R0 or R1) within the past 2 months
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100% (90-100% for patients 71-75 years of age)
- WBC ≥ 3,500/mm\^3
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 2 mg/dL
- SGOT and SGPT ≤ 2 times upper limit of normal
- Not pregnant or nursing
- No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- No psychological, familial, sociological, or geographical condition that would potentially hinder study compliance or follow-up schedule
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
- No other concurrent experimental drugs
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00960284
Start Date
June 1 2003
End Date
June 1 2009
Last Update
January 13 2012
Active Locations (1)
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1
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132