Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
NCT ID: NCT00059826
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2003-03-31
2011-02-28
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Interferon-based chemoradiation therapy
Cycle 1: Chemoradiotherapy (CRT)
* 5-fluorouracil continuous infusion (CI) via an ambulatory infusion pump into a central venous catheter at 175 mg/m2/day for 38 consecutive days, unless toxicity occurs
* cisplatin given on the first day only of each week of this cycle (days 1, 8, 15, 22, 29, 36)
* IFN-alpha-2b 3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks
* XRT 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday - Friday, for 5½ weeks
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
interferon-alfa-2b
IV
cisplatin
IV
5-fluorouracil
IV
radiation therapy
Interventions
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interferon-alfa-2b
IV
cisplatin
IV
5-fluorouracil
IV
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration.
3. Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system.
* NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF.
4. Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 \[no residual tumor\] or R1 \[microscopic residual tumor\]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF.
5. Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration:
* WBC \> 3,000 mm\^3
* ANC \> 1,500 mm\^3
* hemoglobin \> 9.5 mg/dl
* platelet count \> 100,000 mm\^3
* total bilirubin \< 3 mg/dl
* AST (SGOT) \< 2.0 times institutional upper limit of normal (ULN)
* ALT (SGPT) \< 2.0 times institutional ULN
* alkaline phosphatase \< 2.0 times institutional ULN
* serum creatinine \< 1.5 times institutional ULN
7\. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude metastatic disease.
8\. If female of childbearing potential, patient must have a negative urine or serum pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential.
9\. Patient (male or female) of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
10\. Patient, or the patient's legally acceptable representative, must sign and date an informed consent PRIOR to registration and the performance of any study related procedures.
11\. Patient, or the patient's legally acceptable representative, must provide written authorization to allow the use and disclosure of their protected health information.
\- NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.
12\. If patient is a cancer survivor, all of the following criteria must be met and documented in the patient's medical record:
1. Patient has undergone potentially curative therapy for all prior malignancies.
2. No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer).
3. No evidence of recurrence of any prior malignancy.
Exclusion Criteria
2. Patient is pregnant or lactating.
3. Patient has recurrent pancreatic cancer.
4. Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer.
5. Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis.
6. Patient has received any biologic/ immunologic therapies.
7. Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality.
8. Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Vincent J. Picozzi, MD
Role: STUDY_CHAIR
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Locations
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University of Florida Shands Cancer Center
Gainesville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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References
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Picozzi VJ, Abrams RA, Decker PA, Traverso W, O'Reilly EM, Greeno E, Martin RC, Wilfong LS, Rothenberg ML, Posner MC, Pisters PW; American College of Surgeons Oncology Group. Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031. Ann Oncol. 2011 Feb;22(2):348-54. doi: 10.1093/annonc/mdq384. Epub 2010 Jul 29.
Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: initial report of a multicenter, phase II trial of a novel chemoradiation protocol using cisplatin, 5-FU, and alpha- interferon as adjuvant therapy for resected pancreas cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-125, 2008.
Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: report on a multicenter, phase II trial for adjuvant therapy of resected pancreatic cancer using cisplatin, 5- FU, and alpha-interferon. [Abstract] J Clin Oncol 26 (Suppl 15): A-4505, 2008.
Other Identifiers
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CDR0000298776
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z05031
Identifier Type: -
Identifier Source: org_study_id