A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy (IMRT)

This study has been terminated.
(Lack of accrual and software issues)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00608751
First received: January 2, 2008
Last updated: May 22, 2013
Last verified: May 2013

January 2, 2008
May 22, 2013
January 2007
January 2008   (final data collection date for primary outcome measure)
Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy) [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.
We define feasibility as the ability to maintain the planned prescription parameters throughout treatment by delivering 95% of the prescription dose to 99% of the original PTV. [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00608751 on ClinicalTrials.gov Archive Site
  • Measure additional time required by physician and ancillary staff for the process of adaptive IMRT [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Recording on a weekly basis the actual time required for repeat CT imaging, plan re-evaluation, replanning, and repeat physics QA.
  • Identify a subset of patients in whom adaptive IMRT would be recommended [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Measure acute and late toxicity [ Time Frame: Until patient death ] [ Designated as safety issue: Yes ]
  • Local, regional, and distant recurrence [ Time Frame: Until recurrence ] [ Designated as safety issue: No ]
Descriptive statistics will be reported for measured times such as mean, median, standard deviation, and range. [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy
A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer

Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer

In this study, we will plan additional measurements of the position of the patient's organs weekly during radiation treatment. We will analyze these measurements in order to evaluate whether we need to adjust our treatment procedures for the remainder of the treatments. We might adjust the dose of radiation received to specific organs in order to try to minimize the amount of radiation the healthy tissue receives.

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Radiation: IMRT
Experimental: IMRT
External beam radiation with 6 MV photons will be delivered in 200 cGy daily fractions, 35 fractions over 7 weeks for a total dose of 7000 cGy.
Intervention: Radiation: IMRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >= 18
  • Karnofsky Performance Status of >= 60
  • New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.)
  • All stages with measurable gross disease (>= 1.0 cm) by CT imaging
  • Pathologic confirmation of squamous cell carcinoma by biopsy or cytology
  • Signed study-specific consent form
  • Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist)

Exclusion Criteria

  • Age < 18
  • Karnofsky Performance Status < 60
  • Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes)
  • Prior radiation therapy to the head-and-neck region
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00608751
06-1210
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Wade Thorstad, MD Washington University School of Medicine
Washington University School of Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP