Adaptive Radiation Therapy for Head & Neck Cancer Patients
IGRT
Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 30, 2015
September 1, 2014
5.4 years
February 25, 2013
March 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical patient response
This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.
From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).
Secondary Outcomes (1)
Patient quality of life
During radiation therapy (7-9 weeks)
Study Arms (2)
definitive radiation + concomitant chemo
EXPERIMENTALConcurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment
neoadjuvant chemo
EXPERIMENTALNeoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Medical Center
New York, New York, 10003, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken Hu, MD
Beth Israel Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2013
First Posted
May 15, 2013
Study Start
August 1, 2009
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
March 30, 2015
Record last verified: 2014-09