| Phase II Study of Salivary Gland Transfer Surgery Prior to Radiotherapy for the Prevention of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Supportive care, Treatment | Closed | 18 to 80 | RTOG-0244
NCT00068237 |
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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy 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 Radiotherapy - See Chemotherapy
- No prior radiotherapy to the head and neck
- No concurrent intensity-modulated radiotherapy
Surgery 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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Hemoglobin at least 10 g/dL
Hepatic Renal 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
Expected Enrollment 48A total of 11-48 patients will be accrued for this study within 1.6 years. Outcomes Primary Outcome(s)Reproducibility
Secondary Outcome(s)Rate of acute xerostomia
Salivary scan evaluation
Quality of life
Toxicity
Disease-free survival
Overall survival
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.
Trial Contact Information
Trial Lead Organizations Radiation Therapy Oncology Group  | | | | Jha Naresh, MBBS, Protocol chair | | | |
| Registry Information | | | Official Title | | A Phase II Study Of Submandibular Salivary Gland Transfer To The Submental Space Prior To Start Of Radiation Treatment For Prevention Of Radiation-Induced Xerostomia In Head And Neck Cancer Patients | | | Trial Start Date | | 2003-08-05 | | | Registered in ClinicalTrials.gov | | NCT00068237 | | | Date Submitted to PDQ | | 2003-02-27 | | | Information Last Verified | | 2007-08-17 | | | NCI Grant/Contract Number | | CA21661 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
