A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

Head and Neck Cancer Clinical Trial

— IMRT  

Official title:

A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00608751
• Other study ID #: 06-1210
• Status: Terminated
• Phase: Phase 0
• First received: January 2, 2008
• Last updated: May 22, 2013
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• IMRT

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 weeks	Yes
Secondary	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.	7 weeks	No
Secondary	Identify a subset of patients in whom adaptive IMRT would be recommended		7 weeks	No
Secondary	Measure acute and late toxicity		Until patient death	Yes
Secondary	Local, regional, and distant recurrence		Until recurrence	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine