Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
18 Years
N/A
Both
Cancer of Head and Neck
Trial Information
Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
The investigators' secondary objectives for this study are to assess the possibility of
using kV cone beam for treatment replanning as compared to standard the treatment planning,
to determine the need and feasibility of adaptive radiation therapy, to develop concept of
establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH
(P-DVH), to identify tolerance margins, to evaluate local control, locoregional control,
distant metastasis, and overall survival, to assess patient quality of life,and to develop
predictors of patients which may benefit from ART.
Inclusion Criteria:
- Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of
0-2
- Patients should meet at least one of the following criteria:
1. Locally advanced cancer (T3-T4 and/or N2-N3)
2. Tumors wrapping around critical structures such as the optic nerves, optic
chiasm, or brainstem
3. Significant expected weight loss.
Exclusion Criteria:
- Previous surgical procedure more significant than a biopsy to the primary tumor or
regional lymph nodes.
- Poor renal function (inability to undergo a CT with IV contrast)
- Previous radiation therapy to the head and neck.
- Inability to tolerate prolonged immobilization.
- Children and women who are pregnant or decline to use contraception.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical patient response
Outcome Description:
This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.
Outcome Time Frame:
From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).
Safety Issue:
No
Principal Investigator
Ken Hu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Medical Center
Authority:
United States: Institutional Review Board
Study ID:
167-08
NCT ID:
NCT01853670
Start Date:
August 2009
Completion Date:
February 2020
Related Keywords:
- Cancer of Head and Neck
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Beth Israel Medical Center | New York, New York 10003 |
