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

NCT ID: NCT00809016

Last Updated: 2011-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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3-dimensional conformal radiation therapy

Intervention Type RADIATION

fludeoxyglucose F 18

Intervention Type RADIATION

intensity-modulated radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

Principal Investigators

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Eric Lartigau, MD, PhD

Role:

Centre Oscar Lambret

Locations

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Centre Oscar Lambret

Lille, , France

Site Status

Countries

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France

Other Identifiers

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COL-0606

Identifier Type: -

Identifier Source: secondary_id

COL-TEPORL

Identifier Type: -

Identifier Source: secondary_id

COL-RCB 2007-A00291-52

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0488

Identifier Type: -

Identifier Source: secondary_id

CDR0000626776

Identifier Type: -

Identifier Source: org_study_id

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