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

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The Washington University

Status and phase

Terminated
Early Phase 1

Conditions

Head and Neck Cancer

Treatments

Radiation: IMRT

Study type

Interventional

Funder types

Other

Identifiers

NCT00608751
06-1210

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

IMRT
Experimental group
Description:
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.
Treatment:
Radiation: IMRT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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