A Phase II Study of Interferon-Based Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma
- 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
- 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.
PROJECTED ACCRUAL: A total of 93 patients will be accrued for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
Overall survival at 18 months
Vincent J. Picozzi, MD
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|James Graham Brown Cancer Center at University of Louisville||Louisville, Kentucky 40202|
|Fairview University Medical Center - University Campus||Minneapolis, Minnesota 55455|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|Baylor University Medical Center - Houston||Houston, Texas 77030-2399|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Presbyterian Hospital of Dallas||Dallas, Texas 75231|