Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
23. august 2013 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
260
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bari, Italia, 70124
- Rekruttering
- Università degli Studi di Bari
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Ta kontakt med:
- G. Cervellera, MD
- Telefonnummer: 39-080-5478-660
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Cagliari, Italia, 09042
- Rekruttering
- Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
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Ta kontakt med:
- P. Puxeddu, MD
- Telefonnummer: 39-070-5109-6253
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Ferrara, Italia, 44100
- Rekruttering
- Università di Ferrara
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Ta kontakt med:
- C. Calearo, MD
- Telefonnummer: 39-0532-209-296
- E-post: ccv@dns.unife.it
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Florence, Italia, 50134
- Rekruttering
- Universita Degli Studi di Florence - Policlinico di Careggi
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Ta kontakt med:
- O. Fini-Storchi, MD
- Telefonnummer: 39-55-411739
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Turin, Italia, 10126
- Rekruttering
- Università di Torino
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Ta kontakt med:
- G. Valente, MD
- Telefonnummer: 39-011-670-5955
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Turin, Italia, 10128
- Rekruttering
- Azienda Sanitaria Ospedaliera Ordine Mauriziano
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Ta kontakt med:
- G. Forni, MD
- Telefonnummer: 39-11-508-1111
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Vicenza, Italia, 36100
- Rekruttering
- Ospedale San Bortolo
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Ta kontakt med:
- C. Curioni, MD
- Telefonnummer: 39-444-993-906
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 75 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
Hva måler studien?
Primære resultatmål
Resultatmål |
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Svarprosent
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Disease-free survival at 3 and 5 years
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Recurrence/metastasis rate at 3 and 5 years
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Local and systemic effects of treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Giorgio Cortesina, MD, Universita Degli Studi di Turin
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 1992
Datoer for studieregistrering
Først innsendt
1. november 1999
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. august 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. august 2013
Sist bekreftet
1. februar 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000064500
- CNR-9506
- EU-95024
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .