NCT00047125
Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
PHASE3
COMPLETED
NCT00047125
INTERVENTIONAL
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)
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.
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma in cervical lymph node metastasis from an unknown primary tumor
* Histopathological grade WHO 1-3
* Pathological stage N1, N2a, N2b, or N3
* No N2c (i.e., bilateral metastatic nodes)
* No single node in supraclavicular fossa or submandibular area
* No evidence of primary tumor in head and neck, lung, esophageal, or other site
* Prior radical, radical modified, or extended radical dissection within the past 8 weeks
* Selective neck dissection allowed (surgeon must justify why standard procedure was not performed)
* No node excision alone
* R0 or R1 disease after dissection
* No distant metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Able and willing to complete quality of life questionnaires
* No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Concurrent chemotherapy allowed
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Other
* No other prior therapy for carcinoma of unknown primary except neck dissection
Carcinoma of Unknown Primary
- TREATMENT
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: Extensive irradiation + ipsilaterals levels, Selective irradiation
- European Organisation for Research and Treatment of Cancer - EORTC