Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer

Radiation Therapy Oncology Group

Status and phase

Completed

Phase 2

Conditions

Xerostomia

Radiation Toxicity

Head and Neck Cancer

Treatments

Procedure: salivary gland transfer

Radiation: Post-operative radiation therapy

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00068237

RTOG-0244

CDR0000287213

Details and patient eligibility

About

RATIONALE: Moving a salivary gland out of the area that will undergo radiation therapy may protect the gland from side effects of radiation therapy and may prevent xerostomia (dry mouth).

PURPOSE: Phase II trial to study the effectiveness of salivary gland surgery in preventing xerostomia in patients who are undergoing radiation therapy for head and neck cancer.

Full description

OBJECTIVES:

Determine the reproducibility of the surgical technique of submandibular salivary gland transfer in patients with head and neck cancer.
Determine the rate and severity of radiation-induced xerostomia after this surgery in these patients.
Determine the pattern of recurrence, disease-free survival, and overall survival of patients treated with this surgery followed by radiotherapy.
Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgical transfer of the submandibular salivary gland to the submental space.

Within 4-6 weeks after surgery, patients undergo radiotherapy once daily, 5 days a week for 5 ½ to 7 weeks in the absence of disease progression or unacceptable toxicity.

Salivary scans are performed before surgery, at 2-3 weeks after surgery, and then at 6 months from the start of radiotherapy.

Quality of life is assessed at baseline and at 3, 6, and 12 months from the start of radiotherapy.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years and then annually.

PROJECTED ACCRUAL: A total of 11-48 patients will be accrued for this study within 1.6 years.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

One of the following diagnoses:
- Histologically confirmed, previously untreated squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- Head and neck cancer of unknown primary with unilateral metastases to the neck nodes
No N3 disease
No carcinoma of the oral cavity or nasopharynx
No bilateral neck node involvement
No suspicious neck node on the contralateral neck or the side chosen for salivary gland transfer by CT scan or MRI
No pre-epiglottic space involvement
No involvement of level 1 nodes on either side of the neck
No salivary gland malignancy
No recurrent disease

PATIENT CHARACTERISTICS:

Age

At least 18 years old

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin at least 10 g/dL

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No salivary gland disease (e.g., Sjögren's syndrome)
No other malignancy within the past 3 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 3 years since prior chemotherapy
No prior or concurrent neoadjuvant chemotherapy
Concurrent adjuvant chemoradiotherapy (in addition to study radiotherapy) allowed

Endocrine therapy

Not specified

Radiotherapy

See Chemotherapy
No prior radiotherapy to the head and neck
No concurrent intensity-modulated radiotherapy

Surgery

Not specified

Other

No concurrent cholinergic drugs
No concurrent anti-cholinergic drugs
No concurrent tricyclic drugs
No concurrent prophylactic amifostine or pilocarpine during and for at least 3 months after completion of study radiotherapy