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
- 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
- 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
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
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
Masking: Open Label, Primary Purpose: Supportive Care
Jha Naresh, MBBS
Cross Cancer Institute at University of Alberta
United States: Federal Government
|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|