Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Carcinoma of Unknown Primary

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective irradiation<br>Irradiation of the ipsilateral level I - V of the neck up to a dose of 60 Gy (30x2Gy in 6 weeks). | Radiation: radiation therapy<br> <br> |
| Active Comparator: Extensive irradiation + ipsilaterals levels<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newly diagnosed carcinoma of unknown primary, squamous cell carcinoma of unknown primary