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
18 Years
80 Years
Both
Head and Neck Cancer, Radiation Toxicity, Xerostomia
Trial Information
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
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.
PROJECTED ACCRUAL: A total of 11-48 patients will be accrued for this study within 1.6
years.
Inclusion 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
- 18 to 80
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Reproducibility
Principal Investigator
Jha Naresh, MBBS
Investigator Role:
Study Chair
Investigator Affiliation:
Cross Cancer Institute at University of Alberta
Authority:
United States: Federal Government
Study ID:
CDR0000287213
NCT ID:
NCT00068237
Start Date:
August 2003
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Radiation Toxicity
- Xerostomia
- xerostomia
- radiation toxicity
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage I squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- untreated metastatic squamous neck cancer with occult primary
- stage IV squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the oropharynx
- Head and Neck Neoplasms
- Xerostomia
- Radiation Injuries
Name | Location |
|---|---|
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
| Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
