search
Back to results

Adaptive Radiation Therapy for Head & Neck Cancer Patients (IGRT)

Primary Purpose

Cancer of Head and Neck

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
concurrent chemo + IGRT
neoadjuvant chemo + IGRT
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

definitive radiation + concomitant chemo

neoadjuvant chemo

Arm Description

Concurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment

Neoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment.

Outcomes

Primary Outcome Measures

Clinical patient response
This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.

Secondary Outcome Measures

Patient quality of life
This will be assessed using the: Fact Head & Neck form at baseline, and weekly throughout radiation treatment.

Full Information

First Posted
February 25, 2013
Last Updated
March 27, 2015
Sponsor
Beth Israel Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01853670
Brief Title
Adaptive Radiation Therapy for Head & Neck Cancer Patients
Acronym
IGRT
Official Title
Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
definitive radiation + concomitant chemo
Arm Type
Experimental
Arm Description
Concurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment
Arm Title
neoadjuvant chemo
Arm Type
Experimental
Arm Description
Neoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment.
Intervention Type
Radiation
Intervention Name(s)
concurrent chemo + IGRT
Intervention Type
Radiation
Intervention Name(s)
neoadjuvant chemo + IGRT
Primary Outcome Measure Information:
Title
Clinical patient response
Description
This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.
Time Frame
From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).
Secondary Outcome Measure Information:
Title
Patient quality of life
Description
This will be assessed using the: Fact Head & Neck form at baseline, and weekly throughout radiation treatment.
Time Frame
During radiation therapy (7-9 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Locally advanced cancer (T3-T4 and/or N2-N3) Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Hu, MD
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Adaptive Radiation Therapy for Head & Neck Cancer Patients

We'll reach out to this number within 24 hrs