Spots Global Cancer Trial Database for Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
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Trial Identification
Brief Title: Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
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
Study ID: NCT00068237
Study Description
Brief Summary: 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Florida Shands Cancer Center, Gainesville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
Cancer Institute at St. John's Hospital, Springfield, Illinois, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, United States
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
Doctor H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
Contact Details
Name: Naresh Jha, MBBS
Affiliation: Cross Cancer Institute at University of Alberta
Role: STUDY_CHAIR
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