A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

Early Phase 1

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Radiation: IMRT

• Registration Number: NCT00608751
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-02-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)	7 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Measure additional time required by physician and ancillary staff for the process of adaptive IMRT	7 weeks	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	7 weeks
Measure acute and late toxicity	Until patient death
Local, regional, and distant recurrence	Until recurrence

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States