Adaptive Radiation Therapy for Head & Neck Cancer Patients

Not Applicable

Completed

• Conditions: Cancer of Head and Neck
• Interventions: Radiation: concurrent chemo + IGRT; Radiation: neoadjuvant chemo + IGRT

• Registration Number: NCT01853670
• Lead Sponsor: Beth Israel Medical Center

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-15
• Status Verified: 2014-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
definitive radiation + concomitant chemo	concurrent chemo + IGRT	Concurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment
neoadjuvant chemo	neoadjuvant chemo + IGRT	Neoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment.

Primary Outcome Measures

Name	Time	Method
Clinical patient response	From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).	This will assessed by CT scan or MRI 4-5 weeks post concurrent chemo.

Secondary Outcome Measures

Name	Time	Method
Patient quality of life	During radiation therapy (7-9 weeks)	This will be assessed using the: Fact Head \& Neck form at baseline, and weekly throughout radiation treatment.

Trial Locations

Locations (1)

Beth Israel Medical Center; 🇺🇸 New York, New York, United States