Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002702
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
1999-11-01
Brief Title:
Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
Sponsor:
European Institute of Oncology
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2011-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Interleukin-2 may stimulate a persons 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
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 45-65 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
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 45-65 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-95024 | None | None | None |
| CNR-9506 | None | None | None |