Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- disease-free survival
|Study Start Date:||July 2002|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
Experimental: Selective irradiation
Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks).
|Radiation: radiation therapy|
Active Comparator: Extensive irradiation + ipsilaterals levels
Irradiation on the whole mucosa of the larynx, hypopharynx, oropharynx and nasopharynx, and on both sides of the neck (levels I -V) up to a prophylactic dose of 50 Gy (25 x 2 Gy in 5 week).Irradiation of the ipsilateral level I - V of the neck should continue with an additional 10 Gy boost for a total dose of 60 Gy (30 x 2 Gy in 6 weeks).
|Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047125
Show 262 Study Locations
|Study Chair:||Vincent G. Gregoire, MD, PhD||Cliniques universitaires Saint-Luc|
|Study Chair:||Sharon A. Spencer, MD||University of Alabama at Birmingham|
|Study Chair:||Samy El-Sayed, MD, FFR, FRCR, FRCP||Ottawa Regional Cancer Centre|
|Study Chair:||Esat M. Ozsahin, MD, PhD||Centre Hospitalier Universitaire Vaudois|
|Study Chair:||Cai Grau, MD||Aarhus Universitetshospital - Aarhus Sygehus|