A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

NCT00608751 | Terminated Early Phase 1

• 1 other identifier: 06-1210
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer

Keywords

Newly Diagnosed head and neck cancer

Outcome Measures

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.

  7 weeks

Secondary Outcomes (4)

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

  7 weeks

• 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

Study Arms (1)

IMRT

EXPERIMENTAL

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

IMRT RADIATION

IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Wade Thorstad, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (1)