|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068237 |
Purpose
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 | Intervention | Phase |
|
Head and Neck Cancer Oral Complications of Chemotherapy and Head/Neck Radiation |
Procedure: conventional surgery Procedure: radiation therapy Procedure: radioprotection |
Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Salivary Gland Disorders |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Open Label |
| 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 |
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2003 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| 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 | |||||
| Canada, Alberta | |||||
| 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 | |||||
| Canada, Quebec | |||||
| Centre Hospitalier Universitaire de Quebec | |||||
| Quebec City, Quebec, Canada, G1R 2J6 | |||||
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Jha Naresh, MBBS | Cross Cancer Institute at University of Alberta |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000287213, RTOG-0244 |
| First Received: | September 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068237 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|