PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

Head and Neck Cancer Clinical Trial

Official title:

Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809016
• Other study ID #: CDR0000626776
• Secondary ID: COL-0606COL-TEPO
• Status: Completed
• Phase: N/A
• First received: December 13, 2008
• Last updated: May 12, 2011
• Start date: May 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying PET scans to see how well they work in patients with head and neck cancer who are undergoing 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy.

Description:

OBJECTIVES:

Primary

• To assess the value of pre-treatment PET in determining the target volume in patients with head and neck cancer undergoing three-dimensional conformational radiotherapy and intensity-modulated radiotherapy.

Secondary

• To evaluate variations in weekly fludeoxyglucose F 18 PET imaging during the first 5 weeks of treatment.

• To determine the relationship between changes in tumor metabolism during radiotherapy and control tumor at 3 months and at 1 year post-treatment.

OUTLINE: This is a multicenter study.

Patients undergo fludeoxyglucose F18 PET (FDG-PET) in addition to conventional imaging at baseline. Patients undergo standard three-dimensional conformational radiotherapy and intensity-modulated radiation therapy 5 days a week for 5 weeks.

Some patients also undergo weekly FDG-PET during treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed head and neck cancer

• No nasopharyngeal or paranasal sinus cancer

• Locally advanced disease (T3 or T4)

• Not in complete remission

• Planning to undergo curative radiotherapy (minimum dose of 66 Gy), with or without standard treatment (i.e., platinum-based chemotherapy or biological therapy/rituximab)

• Measurable tumor according to RECIST criteria

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Not pregnant or nursing

• Able to lie still for 1 hour

• No history of progressive neoplastic disease

• No known hypersensitivity to fludeoxyglucose F18 or any of its excipients

• No severe or uncontrolled systemic disease, including any of the following:

• Kidney disease

• Liver disease

• Cardiac disease

• Unstable or uncompensated respiration

• Uncontrolled diabetes (i.e., glucose = 1.5 g/L)

• No geographical, social, or psychological conditions that make follow-up impossible

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior surgery

• No concurrent experimental agents

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• 3-dimensional conformal radiation therapy

• fludeoxyglucose F 18

• intensity-modulated radiation therapy

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the target volume to be irradiated as measured by conventional imagining and PET			No