Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00068237|
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : January 31, 2014
Last Update Posted : February 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Radiation Toxicity Xerostomia||Procedure: Surgery for the primary and neck nodes Procedure: Submandibular salivary gland transfer Radiation: Post-operative radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||August 2003|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||December 2016|
Surgery and salivary gland transfer and radiation
Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
|Procedure: Surgery for the primary and neck nodes Procedure: Submandibular salivary gland transfer Radiation: Post-operative radiation therapy|
- Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed "Per Protocol" [ Time Frame: At the time of the submandibular salivary gland transfer ]Surgery will be scored as "per protocol prescription" if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery "per protocol prescription", then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%.
- Rate of Acute Xerostomia [ Time Frame: From start of treatment to 90 days ]
- Salivary Scan Evaluation [ Time Frame: From start of treatment to 6 months ]
- Quality of Life [ Time Frame: From registration to 1 year ]
- Toxicity [ Time Frame: From start of treatment to last follow-up ]
- Disease-free Survival [ Time Frame: From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up ]
- Overall Survival [ Time Frame: From registration to date of death or last follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068237
|United States, Florida|
|University of Florida Shands Cancer Center|
|Gainesville, Florida, United States, 32610-0232|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|Cancer Institute at St. John's Hospital|
|Springfield, Illinois, United States, 62702|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Wisconsin|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Veterans Affairs Medical Center - Milwaukee|
|Milwaukee, Wisconsin, United States, 53295|
|Cross Cancer Institute at University of Alberta|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, Newfoundland and Labrador|
|Doctor H. Bliss Murphy Cancer Centre|
|St. John's, Newfoundland and Labrador, Canada, A1B 3V6|
|Centre Hospitalier Universitaire de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Study Chair:||Naresh Jha, MBBS||Cross Cancer Institute at University of Alberta|