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Clinical Trial Record

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Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer

2003-03

2007-07

2011-02

89

Study Overview

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.

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.

  • Pancreatic Cancer
  • BIOLOGICAL: interferon-alfa-2b
  • DRUG: cisplatin
  • DRUG: 5-fluorouracil
  • RADIATION: radiation therapy
  • ACOSOG-Z05031
  • CDR0000298776 (REGISTRY Identifier) (REGISTRY: NCI Physician Data Query)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2003-05-06  

N/A  

2016-12-05  

2003-05-06  

N/A  

2016-12-07  

2003-05-07  

N/A  

2016-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: 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 wee

BIOLOGICAL: interferon-alfa-2b

  • IV

DRUG: cisplatin

  • IV

DRUG: 5-fluorouracil

  • IV

RADIATION: radiation therapy

Primary Outcome MeasuresMeasure DescriptionTime Frame
Overall survival at 18 monthsat 18 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Toxicityat 18 months
Disease-free survivalat 18 months
Local-regional disease controlat 18 months
Distant disease controlat 18 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Patient must be > 18 years of age. 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:
    1. Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma. 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • National Cancer Institute (NCI)
  • STUDY_CHAIR: Vincent J. Picozzi, MD, Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
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