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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Radiation: concurrent chemo + IGRT; Radiation: neoadjuvant chemo + IGRT

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: definitive radiation + concomitant chemo; Concurrent chemo + IGRT: These patients will have chemotherapy during the time of radiation treatment	Radiation: concurrent chemo + IGRT
Experimental: neoadjuvant chemo; Neoadjuvant chemo + IGRT: These patients will have chemotherapy prior to other radiation treatment.	Radiation: neoadjuvant chemo + IGRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beth Israel Medical Center
• Investigators: Principal Investigator: Ken Hu, MD, Beth Israel Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 15, 2013

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 167-08