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Completed

NCT Number: NCT01853670

Adaptive Radiation Therapy for Head & Neck Cancer Patients

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.

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Key information

Conditions

Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Medical Center

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

concurrent chemo + IGRT

Radiation

neoadjuvant chemo + IGRT

Radiation

Primary outcomes

  1. Clinical patient response

    Time frame: 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 outcomes

  1. Patient quality of life

    Time frame: During radiation therapy (7-9 weeks)

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

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Official study title

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

Acronym: IGRT

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 15, 2013
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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