Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047125
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2002-10-03
Brief Title:
Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase III Study On The Selection Of The Target Volume In Postoperative Radiotherapy For Cervical Lymph Node Metastases Of Squamous Cell Carcinoma From And Unknown Primary CUP
Status:
COMPLETED
Status Verified Date:
2018-07
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 uses high-energy x-rays to damage tumor cells Giving radiation therapy in different ways may kill more tumor cells It is not yet known which regimen of radiation therapy is more effective in treating patients who have metastases to the lymph nodes in the neck
PURPOSE Randomized phase III trial to compare different radiation therapy regimens in treating patients who have metastases to the lymph nodes in the neck from an unknown primary tumor
PURPOSE Randomized phase III trial to compare different radiation therapy regimens in treating patients who have metastases to the lymph nodes in the neck from an unknown primary tumor
Detailed Description:
OBJECTIVES
Compare the disease-free survival of patients with cervical lymph node metastases of squamous cell carcinoma from an unknown primary treated with selective irradiation vs extensive irradiation
Compare the overall survival of patients treated with these regimens
Compare the incidence of acute and late side effects in the head and neck region in patients treated with these regimens
Compare control of the neck and incidence of subsequent primary in the head and neck region in patients treated with these regimens
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease stage N1-2a vs N2b-3 radiation technique 2D vs 3D conformal vs intensity-modulated and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo selective irradiation of the ipsilateral level of the neck once daily 5 days a week for 6 weeks
Arm II Patients undergo extensive irradiation of the neck nasopharyngeal oropharyngeal hypopharyngeal and laryngeal mucosa and ipsilateral neck node areas on both sides of the neck once daily 5 days a week for 6 weeks
In both arms treatment continues in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline at week 4 on the last day of therapy and then every 3 months for 1 year
Patients are followed at day 30 every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study within 7 years
Compare the disease-free survival of patients with cervical lymph node metastases of squamous cell carcinoma from an unknown primary treated with selective irradiation vs extensive irradiation
Compare the overall survival of patients treated with these regimens
Compare the incidence of acute and late side effects in the head and neck region in patients treated with these regimens
Compare control of the neck and incidence of subsequent primary in the head and neck region in patients treated with these regimens
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease stage N1-2a vs N2b-3 radiation technique 2D vs 3D conformal vs intensity-modulated and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo selective irradiation of the ipsilateral level of the neck once daily 5 days a week for 6 weeks
Arm II Patients undergo extensive irradiation of the neck nasopharyngeal oropharyngeal hypopharyngeal and laryngeal mucosa and ipsilateral neck node areas on both sides of the neck once daily 5 days a week for 6 weeks
In both arms treatment continues in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline at week 4 on the last day of therapy and then every 3 months for 1 year
Patients are followed at day 30 every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 600 patients 300 per treatment arm will be accrued for this study within 7 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-EORTC-24001 | None | None | None |
| EORTC-24001 | None | None | None |
| EORTC-22005 | None | None | None |
| DAHANCA-EORTC-24001 | None | None | None |
| CAN-NCIC-EORTC-24001 | None | None | None |