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

5 dicembre 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

89

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Radiazione: radioterapia
Altri nomi:
  • XRT
Droga: cisplatino
IV
Biologico: interferon-alfa-2b
IV
Altri nomi:
  • IFN-alpha-2b
Droga: 5-fluorouracile
IV
Altri nomi:
  • 5-FU

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Overall survival at 18 months
Lasso di tempo: at 18 months
at 18 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Toxicity
Lasso di tempo: at 18 months
at 18 months
Sopravvivenza libera da malattia
Lasso di tempo: a 18 mesi
a 18 mesi
Local-regional disease control
Lasso di tempo: at 18 months
at 18 months
Distant disease control
Lasso di tempo: at 18 months
at 18 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2003

Completamento primario (Effettivo)

1 luglio 2007

Completamento dello studio (Effettivo)

1 febbraio 2011

Date di iscrizione allo studio

Primo inviato

6 maggio 2003

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2003

Primo Inserito (Stima)

7 maggio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 dicembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 dicembre 2016

Ultimo verificato

1 dicembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACOSOG-Z05031
  • CDR0000298776 (Identificatore di registro: NCI Physician Data Query)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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