Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different
ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may
interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from
x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa
and giving them with radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and
interferon alfa in treating patients who have resected stage I, stage II, or stage III
pancreatic cancer.
OBJECTIVES:
- Determine the disease-free and overall survival of patients with resected pancreatic
adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil,
cisplatin, and interferon alfa.
- Determine the rate and severity of acute and late toxic effects in patients treated
with this regimen.
- Determine the local-regional disease control and distant disease control in patients
treated with this regimen.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy (CRT): Patients receive fluorouracil IV continuously on days 1-38;
cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa
subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and
38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and
36-38.
- Post-CRT chemotherapy: Beginning 4-6 weeks after the completion of CRT, patients
receive fluorouracil IV continuously on days 1-42. Treatment repeats every 56 days for
a total of two courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months
for 1 year, every 6 months for 1 year, and then annually thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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