|Phase III||Treatment||Completed||18 and over||NCI, Other||CDR0000066076|
RTOG-9704, E-R9704, SWOG-R9704, NCT00003216
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery.
Further Study Information
- Compare the overall and disease-free survival of patients with resected adenocarcinoma of the pancreas treated with adjuvant fluorouracil-based chemoradiotherapy preceded and followed by fluorouracil vs gemcitabine.
- Compare the local-regional and distant disease control in patients treated with these regimens.
- Compare the acute and late toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal involvement (yes vs no), tumor diameter (less than 3 cm vs 3 cm or greater), and surgical margins (negative vs positive vs unknown). Patients are randomized to one of two treatment arms.
- Arm I: Beginning 3-8 weeks after definitive surgical resection, patients receive fluorouracil IV continuously for 3 weeks. Beginning 1-2 weeks later, patients receive fluorouracil IV continuously concurrently with radiotherapy 5 days a week for 5.5 weeks. Beginning 3-5 weeks after completion of chemoradiotherapy, patients receive fluorouracil IV continuously for 4 weeks every 6 weeks for 2 courses.
- Arm II: Beginning 3-8 weeks after definitive surgical resection, patients receive gemcitabine IV once weekly for 3 weeks. Beginning 1-2 weeks later, patients receive chemoradiotherapy as in arm I. Beginning 3-5 weeks after completion of chemoradiotherapy, patients receive gemcitabine IV once weekly for 3 weeks every 4 weeks for 3 courses.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 518 patients will be accrued for this study within 8.6 years.
- Histologically confirmed adenocarcinoma of the pancreas
- Stage T1-4, N0-1 (stage I-IVA)
- No M1 or NX staging
- Primary tumor of the pancreas (pancreatic head, neck, uncinate process, or body/tail) and maximum diameter/dimension and tumor status at surgical margin known
- Prior potentially curative gross resection within 3-8 weeks before study
- No non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct carcinoma, or ampullary carcinoma
- No recurrent disease
- Post-resection CA-19-9 level required
- 18 and over
- Karnofsky 60-100%
- Not specified
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 5 times ULN
- Creatinine no greater than 1.5 times ULN
- No significant nausea or vomiting
- No prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Able to maintain adequate nutrition (at least 1,500 calories/day)
- Feeding tube allowed
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Not specified
- No prior chemotherapy
- Not specified
- No prior radiotherapy
- See Disease Characteristics
Trial Lead Organizations/Sponsors
Radiation Therapy Oncology GroupNational Cancer Institute
Eastern Cooperative Oncology Group
Southwest Oncology Group
|William F. Regine||Study Chair|
|Al Bowen Benson||Study Chair|
|John S. MacDonald||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003216
Information obtained from ClinicalTrials.gov on November 20, 2012
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