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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
This study has been completed.
Sponsor:
Centre Oscar Lambret
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00809016
First received: December 13, 2008
Last updated: May 12, 2011
Last verified: July 2009
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Purpose
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 | Intervention |
|---|---|
| Head and Neck Cancer | Radiation: 3-dimensional conformal radiation therapy Radiation: fludeoxyglucose F 18 Radiation: intensity-modulated radiation therapy |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Head and Neck Cancer
Genetic and Rare Diseases Information Center resources:
Adenoid Cystic Carcinoma
Cylindroma
Laryngeal Cancer
Hypopharyngeal Cancer
Acinic Cell Carcinoma
Metastatic Squamous Neck Cancer With Occult Primary
Mucoepidermoid Carcinoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Difference between the target volume to be irradiated as measured by conventional imagining and PET
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00809016
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809016
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
| ClinicalTrials.gov Identifier: | NCT00809016 History of Changes |
| Other Study ID Numbers: |
CDR0000626776 COL-0606 COL-TEPORL COL-RCB 2007-A00291-52 INCA-RECF0488 |
| Study First Received: | December 13, 2008 |
| Last Updated: | May 12, 2011 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017