Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
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.
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma|
- Overall survival at 18 months [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: at 18 months ] [ Designated as safety issue: Yes ]
- Disease-free survival [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
- Local-regional disease control [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
- Distant disease control [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Study Completion Date:||February 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Interferon-based chemoradiation therapy
Cycle 1: Chemoradiotherapy (CRT)
Cycles 2 and 3: Post-CRT Chemotherapy
Post-CRT chemotherapy starts 4 - 6 weeks after completion of Cycle 1, unless the study physician deems further delay is necessary. Patients will be given 2 cycles of chemotherapy (cycles 2 and 3).
-- 5-fluorouracil continuous infusion via an ambulatory infusion pump into a central venous catheter at 200 mg/m2/day for 6 weeks followed by 2 weeks of rest
Other Name: IFN-alpha-2bDrug: cisplatin
Other Name: 5-FURadiation: radiation therapy
Other Name: XRT
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059826
|United States, Florida|
|University of Florida Shands Cancer Center|
|Gainesville, Florida, United States, 32610-0232|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Kentucky|
|James Graham Brown Cancer Center at University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Fairview University Medical Center - University Campus|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Presbyterian Hospital of Dallas|
|Dallas, Texas, United States, 75231|
|Baylor University Medical Center - Houston|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Vincent J. Picozzi, MD||Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center|