Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206752
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2005-09-13
Brief Title:
Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck
Sponsor:
Beth Israel Medical Center
Organization:
Beth Israel Medical Center
Study Overview
Official Title:
A Randomized Prospective Evaluation of UnilateralIpsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Unilateral
Brief Summary:
The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck We aim to assess the reduction in treatment volume amount of radiation therapy required and the resultant xerostomia and mucositis with the delivery of unilateral neck radiation therapy
Detailed Description:
Patients will be treated with definitive external beam radiation plusminus chemotherapy plusminus neck dissection in the ipsilateral neck post radiation The primary site will be treated with definitive radiation therapy or definitive surgery plus post-operative radiation therapy Primary endpoints are loco-regional control as well as quality of life xerostomia mucositis and neck fibrosis
Salivary evaluations shall be performed prior to the initiation of radiation therapy during the second week of EBRT and at the completion of radiation Evaluations will also be conducted at 3 6 and 12 months after the completion of EBRT
Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT Evaluations will also be conducted at 3 and 6 months after the completion of EBRT Two standardized mucositis scales will be used the RTOG scale and the WHO scale
Clinical response will be evaluated by physical exam and PETCT PETCT scans will be done at 3 6 12 18 and 24 months and then when clinically indicated during follow-up
Salivary evaluations shall be performed prior to the initiation of radiation therapy during the second week of EBRT and at the completion of radiation Evaluations will also be conducted at 3 6 and 12 months after the completion of EBRT
Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT Evaluations will also be conducted at 3 and 6 months after the completion of EBRT Two standardized mucositis scales will be used the RTOG scale and the WHO scale
Clinical response will be evaluated by physical exam and PETCT PETCT scans will be done at 3 6 12 18 and 24 months and then when clinically indicated during follow-up
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 |
|---|---|---|---|
| ETH136-03D | None | None | None |