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

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.

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