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

5. december 2016 opdateret af: Alliance for Clinical Trials in Oncology

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

89

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-0232
        • University of Florida Shands Cancer Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • James Graham Brown Cancer Center at University of Louisville
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Fairview University Medical Center - University Campus
    • New York
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Presbyterian Hospital of Dallas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor University Medical Center - Houston
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Stråling: strålebehandling
Andre navne:
  • XRT
Medicin: cisplatin
IV
Biologisk: interferon-alfa-2b
IV
Andre navne:
  • IFN-alpha-2b
Medicin: 5-fluoruracil
IV
Andre navne:
  • 5-FU

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Overall survival at 18 months
Tidsramme: at 18 months
at 18 months

Sekundære resultatmål

Resultatmål
Tidsramme
Toxicity
Tidsramme: at 18 months
at 18 months
Sygdomsfri overlevelse
Tidsramme: ved 18 måneder
ved 18 måneder
Local-regional disease control
Tidsramme: at 18 months
at 18 months
Distant disease control
Tidsramme: at 18 months
at 18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Vincent J. Picozzi, MD, Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2003

Primær færdiggørelse (Faktiske)

1. juli 2007

Studieafslutning (Faktiske)

1. februar 2011

Datoer for studieregistrering

Først indsendt

6. maj 2003

Først indsendt, der opfyldte QC-kriterier

6. maj 2003

Først opslået (Skøn)

7. maj 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACOSOG-Z05031
  • CDR0000298776 (Registry Identifier: NCI Physician Data Query)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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