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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Radiation: 3-dimensional conformal radiation therapy; Radiation: fludeoxyglucose F 18; Radiation: intensity-modulated radiation therapy	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Non-Randomized
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors
Study Start Date :	May 2007
Actual Primary Completion Date :	May 2011

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Difference between the target volume to be irradiated as measured by conventional imagining and PET

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

France
Centre Oscar Lambret
Lille, France, 59020

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

OverallOfficial:	Eric Lartigau, MD, PhD	Centre Oscar Lambret

More Information

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ClinicalTrials.gov Identifier:	NCT00809016 History of Changes
Other Study ID Numbers:	CDR0000626776; COL-0606; COL-TEPORL; COL-RCB 2007-A00291-52; INCA-RECF0488
First Posted:	December 16, 2008
Last Update Posted:	May 13, 2011
Last Verified:	July 2009

Keywords provided by National Cancer Institute (NCI):

salivary gland acinic cell tumor; recurrent squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; recurrent adenoid cystic carcinoma of the oral cavity; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent verrucous carcinoma of the oral cavity; stage III adenoid cystic carcinoma of the oral cavity; stage III mucoepidermoid carcinoma of the oral cavity

stage III verrucous carcinoma of the oral cavity; stage IV adenoid cystic carcinoma of the oral cavity; stage IV mucoepidermoid carcinoma of the oral cavity; stage IV verrucous carcinoma of the oral cavity; recurrent basal cell carcinoma of the lip; recurrent squamous cell carcinoma of the lip and oral cavity; stage III basal cell carcinoma of the lip; stage III squamous cell carcinoma of the lip and oral cavity; stage IV basal cell carcinoma of the lip; stage IV squamous cell carcinoma of the lip and oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; untreated metastatic squamous neck cancer with occult primary; recurrent lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms	Fluorodeoxyglucose F18; Radiopharmaceuticals; Molecular Mechanisms of Pharmacological Action