Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068237
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2003-09-10
Brief Title:
Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 16 years
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 16 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000287213 | None | None | None |