Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00002702
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival at 3 and 5 years Recurrence/metastasis rate at 3 and 5 years Response rate Local and systemic effects of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Universita di Ferrara
🇮🇹Ferrara, Italy
Cattedra di Oncologia Medica - Universita degli Studi di Cagliari
🇮🇹Cagliari, Italy
Universita Degli Studi di Florence - Policlinico di Careggi
🇮🇹Florence, Italy
Ospedale San Bortolo
🇮🇹Vicenza, Italy
Universita di Torino
🇮🇹Turin, Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano
🇮🇹Turin, Italy
Universita Degli Studi di Bari
🇮🇹Bari, Italy