Status:
COMPLETED
Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Stage II Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable panc...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplati...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Unresectable disease, including subtotal resection and gross residual disease
- Locally advanced disease
- No cystadenocarcinoma of the pancreas
- No pancreatic tumors of neuroendocrine origin
- No microscopic residual disease as only evidence of pancreatic cancer
- All disease must be encompassable within standard radiotherapy fields for pancreatic cancer
- No distant metastases (liver or lung metastases or peritoneal spread)
- No evidence of metastatic disease outside the planned radiotherapy field
- Performance status - ECOG 0-1
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to maintain adequate oral nutrition
- No significant infection
- No significant nausea or vomiting
- No other medical condition that would preclude study participation
- No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score \< 7)
- No known allergy to platinum compounds
- No prior biologic therapy
- No concurrent biologic therapy
- No concurrent immunotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
- No prior radiotherapy that would overlap planned radiotherapy fields
- No other concurrent radiotherapy
- See Disease Characteristics
- At least 21 days since prior laparotomy
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00096070
Start Date
December 1 2004
Last Update
July 16 2013
Active Locations (1)
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1
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905