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TerminatedNCT00608751IMRTUpdated May 24, 2013

A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

An Early Phase 1 interventional study of IMRT in Head and Neck Cancer, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-24.

Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Treatment

Why this study was terminated
Lack of accrual and software issues
Phase
Early Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Head and Neck Cancer

Keywords

  • Newly Diagnosed head and neck cancer
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In context

Head and Neck Neoplasms

2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

This study's enrollment of 5 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • 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.

    Radiation: IMRT

Interventions

  • RadiationIMRT
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What researchers measure

Primary outcomes

  1. Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)

    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.

    Time frame: 7 weeks

Secondary outcomes

  1. Measure additional time required by physician and ancillary staff for the process of adaptive IMRT

    Recording on a weekly basis the actual time required for repeat CT imaging, plan re-evaluation, replanning, and repeat physics QA.

    Time frame: 7 weeks

  2. Identify a subset of patients in whom adaptive IMRT would be recommended

    Time frame: 7 weeks

  3. Measure acute and late toxicity

    Time frame: Until patient death

  4. Local, regional, and distant recurrence

    Time frame: Until recurrence

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Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00608751
Responsible party
Sponsor
First posted
Feb 6, 2008
Start date
Jan 2007
Primary completion
Jan 2008
Completion
Jan 2008
Last update
May 24, 2013

Study contacts

Wade Thorstad, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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