Adaptive Radiation Therapy for Head & Neck Cancer Patients

Cancer of Head and Neck Clinical Trial

— IGRT  

Official title:

Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853670
• Other study ID #: 167-08
• Status: Completed
• Phase: N/A
• First received: February 25, 2013
• Last updated: March 27, 2015
• Start date: August 2009
• Est. completion date: January 2015

Study information

• Verified date: September 2014
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Radiation:
• concurrent chemo + IGRT

• neoadjuvant chemo + IGRT

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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)	No