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Adaptive Radiation Therapy for Head & Neck Cancer Patients (IGRT)

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ClinicalTrials.gov Identifier: NCT01853670
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Radiation: concurrent chemo + IGRT Radiation: neoadjuvant chemo + IGRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
Study Start Date : August 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853670


Locations
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United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
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Principal Investigator: Ken Hu, MD Beth Israel Medical Center
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Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01853670    
Other Study ID Numbers: 167-08
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: September 2014
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms