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

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ClinicalTrials.gov Identifier: NCT00809016
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : May 13, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 13, 2008
First Posted Date  ICMJE December 16, 2008
Last Update Posted Date May 13, 2011
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2008)
Difference between the target volume to be irradiated as measured by conventional imagining and PET
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00809016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy
Official Title  ICMJE Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Radiation: 3-dimensional conformal radiation therapy
  • Radiation: fludeoxyglucose F 18
  • Radiation: intensity-modulated radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 13, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809016
Other Study ID Numbers  ICMJE CDR0000626776
COL-0606
COL-TEPORL
COL-RCB 2007-A00291-52
INCA-RECF0488
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centre Oscar Lambret
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Eric Lartigau, MD, PhD Centre Oscar Lambret
PRS Account National Cancer Institute (NCI)
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP