Status:
COMPLETED
Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery
Lead Sponsor:
Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radia...
Detailed Description
OBJECTIVES: Primary * Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride, cisplatin, and radiotherapy is better than immediate surgery, in terms of median survival,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreatic head
- No tumors of the body or tail, as defined by a tumor lying between the left border of the superior mesenteric vein and the left border of the aorta and/or the left border of the aorta and the hilum of the spleen
- Locally resectable disease by CT scan
- Major vessels (e.g., portal vein, confluence of mesenteric and splenic vein, superior mesenteric artery, celiac trunk, splenic artery, hepatic artery, or superior mesenteric vein) maximally enclosed ≤ 180° by the tumor
- No infiltration of extrapancreatic organs except the duodenum
- No carcinoma of the ampulla of Vater
- No metastasis
- No peritoneal carcinoma
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Creatinine clearance \> 70 mL/min
- Creatinine \< 1.5 mg/dL
- Platelet count \> 100,000/mm³
- No liver cirrhosis
- Not pregnant
- No New York Heart Association class III or IV heart disease
- No respiratory insufficiency
- No grade III or IV cardiac arrhythmias
- No pathology on EKG
- No other severe cardiopulmonary disease
- No HIV infection
- No other disease that renders the patient unsuitable for one treatment option
- No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient was treated with surgery only and has been in complete remission for ≥ 10 years
- PRIOR CONCURRENT THERAPY:
- At least 3 months since prior participation in another clinical trial
- No prior or other concurrent treatment for carcinoma of the pancreas
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00335543
Start Date
June 1 2003
End Date
October 1 2009
Last Update
August 12 2013
Active Locations (17)
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1
Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
2
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
3
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
Berlin, Germany, D-13125
4
Knappschaft Krankenhaus
Bochum, Germany, D-44892