Viewing Study NCT00047008



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00047008
Status: COMPLETED
Last Update Posted: 2023-07-07
First Post: 2002-10-03

Brief Title: Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
Sponsor: Radiation Therapy Oncology Group
Organization: Radiation Therapy Oncology Group

Study Overview

Official Title: A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Status: COMPLETED
Status Verified Date: 2023-04
Last Known Status: None
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 Radiation therapy RT uses high-energy x-rays to damage tumor cells Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer

PURPOSE Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer
Detailed Description: OBJECTIVES

Primary

Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin with or without surgical resection

Secondary

Compare local-regional control of disease and disease-free rates in patients treated with these regimens
Compare the acute and late toxicity of these regimens in these patients
Compare quality of life perception of side effects and performance status of patients treated with these regimens
Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens

OUTLINE This is a randomized multicenter study Patients are stratified according to tumor site larynx vs other nodal stage N0 vs N1 or N2a or N2b vs N2c or N3 and Zubrod performance status 0 vs 1 Patients are randomized to 1 of 2 treatment arms

Arm I Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks Patients also receive cisplatin IV on days 1 22 and 43
Arm II Patients undergo accelerated fractionation radiotherapy 5 days a week for 35 weeks and then twice a day 5 days a week for 25 weeks Patients also receive cisplatin IV on days 1 and 22

Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy undergo surgical resection of the primary tumor

Quality of life is assessed at baseline during one of the last 2 weeks of treatment at 3 and 12 months and then annually for 4 years

Patients are followed at 6-8 weeks every 3 months for 2 years every 6 months for 3 years and then annually thereafter

PROJECTED ACCRUAL A total of 720 patients 360 per treatment arm will be accrued for this study within 3 years

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
RTOG-H-0129 None None None
CDR0000257233 None None None