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
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2007-05-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
DIAGNOSTIC
NONE
Interventions
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3-dimensional conformal radiation therapy
fludeoxyglucose F 18
intensity-modulated radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Oscar Lambret
OTHER
Principal Investigators
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Eric Lartigau, MD, PhD
Role:
Centre Oscar Lambret
Locations
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Centre Oscar Lambret
Lille, , France
Countries
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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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