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Completed

NCT Number: NCT00809016

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Salivary Gland Diseases Salivary Gland Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3-Dimensional Conformal Radiation Therapy

Radiation

fludeoxyglucose F 18

Radiation

Intensity-Modulated Radiation Therapy

Radiation

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
First posted
Dec 16, 2008
Registry last updated
May 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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