Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
Recruitment status was: Recruiting
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.
Head and Neck Cancer
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
- Disease-free survival at 3 and 5 years [ Designated as safety issue: No ]
- Recurrence/metastasis rate at 3 and 5 years [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Local and systemic effects of treatment [ Designated as safety issue: No ]
|Study Start Date:||September 1992|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002702
|Universita Degli Studi di Bari|
|Bari, Italy, 70124|
|Cattedra di Oncologia Medica - Universita degli Studi di Cagliari|
|Cagliari, Italy, 09042|
|Universita di Ferrara|
|Ferrara, Italy, 44100|
|Universita Degli Studi di Florence - Policlinico di Careggi|
|Florence, Italy, 50134|
|Universita di Torino|
|Turin, Italy, 10126|
|Azienda Sanitaria Ospedaliera Ordine Mauriziano|
|Turin, Italy, 10128|
|Ospedale San Bortolo|
|Vicenza, Italy, 36100|
|Study Chair:||Giorgio Cortesina, MD||Universita Degli Studi di Turin|