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Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx

23. august 2013 opdateret af: European Institute of Oncology

Multicentre Randomised Trial of Inductive and Adjuvant Perilymphatically Injected Proleukin (rlL-2) in The Treatment of Operable Primary Squamous Cell Carcinoma of The Oral Cavity and Oropharynx

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells of the mouth or oropharynx. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not known whether giving interleukin-2 with surgery and radiation therapy is more effective than surgery and radiation therapy alone.

PURPOSE: This randomized phase III trial is studying surgery and radiation therapy alone to see how well they work compared to surgery, radiation therapy, and interleukin-2 in treating patients with cancer of the mouth or oropharynx.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the disease-free and overall survival in patients with previously untreated squamous cell carcinoma of the oral cavity or oropharynx treated with resection with or without and neoadjuvant and adjuvant perilymphatic interleukin-2 (IL-2) and radiotherapy.
  • Compare the response rate in patients treated with these regimens.
  • Determine the local and systemic effects of locoregional IL-2 on host-tumor interaction and immune properties in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and tumor stage (T2, N0-2 vs T2, N3 or T3-4, N0-3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo induction comprising interleukin-2 (IL-2) via perilymphatic injections to the ipsilateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5 and 8-12. Within 10 days after the last IL-2 injection, patients undergo en bloc resection of the primary tumor and corresponding lymphatic drainage area and pre-study margins. Beginning within 4 weeks after surgery, patients with T2, N0-3 disease but with pathohistological evidence of node invasion or capsular rupture of node metastasis or T3-4, N0-3 disease undergo adjuvant radiotherapy 5 days a week for 4.5-6.5 weeks. Beginning within 4 weeks after surgery or radiotherapy (if applicable), patients receive adjuvant IL-2 via perilymphatic injections to the contralateral myelohyoid muscle and insertion of the sternocleidomastoid muscle on days 1-5. Adjuvant IL-2 continues monthly for at least 1 year in the absence of disease progression.
  • Arm II: Patients undergo resection and radiotherapy (if eligible) as in arm I. Patients are followed monthly for 1 year and then every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 260 patients (130 per treatment arm) will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

260

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Italien
      • Bari, Italien, 70124
        • Rekruttering
        • Università degli Studi di Bari
        • Kontakt:
          • G. Cervellera, MD
          • Telefonnummer: 39-080-5478-660
      • Cagliari, Italien, 09042
        • Rekruttering
        • Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
        • Kontakt:
          • P. Puxeddu, MD
          • Telefonnummer: 39-070-5109-6253
      • Ferrara, Italien, 44100
        • Rekruttering
        • Università di Ferrara
        • Kontakt:
      • Florence, Italien, 50134
        • Rekruttering
        • Universita Degli Studi di Florence - Policlinico di Careggi
        • Kontakt:
          • O. Fini-Storchi, MD
          • Telefonnummer: 39-55-411739
      • Turin, Italien, 10126
        • Rekruttering
        • Università di Torino
        • Kontakt:
          • G. Valente, MD
          • Telefonnummer: 39-011-670-5955
      • Turin, Italien, 10128
        • Rekruttering
        • Azienda Sanitaria Ospedaliera Ordine Mauriziano
        • Kontakt:
          • G. Forni, MD
          • Telefonnummer: 39-11-508-1111
      • Vicenza, Italien, 36100
        • Rekruttering
        • Ospedale San Bortolo
        • Kontakt:
          • C. Curioni, MD
          • Telefonnummer: 39-444-993-906

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

Ikke ældre end 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically proven squamous cell carcinoma of the oral cavity or oropharynx

    • Operable, primary, unilateral, stage T2-4, N0-3, M0 disease
    • No high probability of bilateral lymphatic spread (requirement for bilateral neck dissection)

  • No tumor involvement of the following sites:

    • Pterygopalatine fossa
    • Carotid artery
    • Maxillary sinus
    • Facial skin
    • Anterior floor of the mouth
    • Base of the tongue infiltrating more than 1 cm
  • Measurable or evaluable disease by physical exam and/or noninvasive imaging

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 4,000/mm3
  • Platelet count at least 60,000/mm3
  • Hematocrit at least 30%

Hepatic:

  • Bilirubin normal
  • Hepatitis B surface antigen negative

Renal:

  • Creatinine normal

Cardiovascular:

  • No congestive heart failure
  • No uncontrolled hypertension
  • No coronary artery disease
  • No serious arrhythmia
  • No evidence of prior myocardial infarction on ECG (stress test required if in doubt)

Other:

  • HIV negative
  • No autoimmune disease
  • No contraindications to pressor agents
  • No serious infection requiring antibiotics
  • No other concurrent primary malignancy
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior or other concurrent immunotherapy

Chemotherapy:

  • No prior or concurrent chemotherapy

Endocrine therapy:

  • No prior or concurrent hormonal therapy
  • No concurrent corticosteroids

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  • No prior major organ allografts

Other:

  • No other prior therapy
  • No other concurrent investigational drugs, agents, or devices
  • No concurrent nonsteroidal antiinflammatory drugs, ranitidine, cimetidine, or coumarin

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: Randomiseret

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Svarprocent
Disease-free survival at 3 and 5 years
Recurrence/metastasis rate at 3 and 5 years
Local and systemic effects of treatment

Samarbejdspartnere og efterforskere

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

Sponsor

European Institute of Oncology

Efterforskere

  • Studiestol: Giorgio Cortesina, MD, Universita Degli Studi di Turin

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. september 1992

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. august 2013

Sidst verificeret

1. februar 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000064500
  • CNR-9506
  • EU-95024

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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