Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
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|ClinicalTrials.gov Identifier: NCT00002702|
Recruitment Status : Unknown
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : January 27, 2003
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: aldesleukin Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|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|
|Study Start Date :||September 1992|
- Disease-free survival at 3 and 5 years
- Recurrence/metastasis rate at 3 and 5 years
- Response rate
- Local and systemic effects of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002702
|Universita Degli Studi di Bari||Recruiting|
|Bari, Italy, 70124|
|Contact: G. Cervellera, MD 39-080-5478-660|
|Cattedra di Oncologia Medica - Universita degli Studi di Cagliari||Recruiting|
|Cagliari, Italy, 09042|
|Contact: P. Puxeddu, MD 39-070-5109-6253|
|Universita di Ferrara||Recruiting|
|Ferrara, Italy, 44100|
|Contact: C. Calearo, MD 39-0532-209-296 firstname.lastname@example.org|
|Universita Degli Studi di Florence - Policlinico di Careggi||Recruiting|
|Florence, Italy, 50134|
|Contact: O. Fini-Storchi, MD 39-55-411739|
|Universita di Torino||Recruiting|
|Turin, Italy, 10126|
|Contact: G. Valente, MD 39-011-670-5955|
|Azienda Sanitaria Ospedaliera Ordine Mauriziano||Recruiting|
|Turin, Italy, 10128|
|Contact: G. Forni, MD 39-11-508-1111|
|Ospedale San Bortolo||Recruiting|
|Vicenza, Italy, 36100|
|Contact: C. Curioni, MD 39-444-993-906|
|Study Chair:||Giorgio Cortesina, MD||Universita Degli Studi di Turin|