PET Scans in Patients With Head And Neck Cancer Who Are U... | NCT00809016 | Trialant
NCT00809016
Sponsor
Centre Oscar Lambret
Status
Completed
Last Update Posted
May 13, 2011Estimated
Enrollment
40Estimated
Phase
Not Applicable
Conditions
Head and Neck Cancer
Interventions
3-dimensional conformal radiation therapy
fludeoxyglucose F 18
intensity-modulated radiation therapy
Countries
France
Protocol Section
Identification Module
NCT ID
NCT00809016
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000626776
Secondary IDs
ID
Type
Description
Link
COL-0606
COL-TEPORL
COL-RCB 2007-A00291-52
INCA-RECF0488
Brief Title
PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy
Official Title
Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Jul 2009
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2007
Primary Completion Date
May 2011Actual
Completion Date
Not provided
First Submitted Date
Dec 13, 2008
First Submission Date that Met QC Criteria
Dec 13, 2008
First Posted Date
Dec 16, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 12, 2011
Last Update Posted Date
May 13, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Centre Oscar LambretOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
Head and Neck Cancer
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
40Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
3-dimensional conformal radiation therapy
Radiation
fludeoxyglucose F 18
Radiation
intensity-modulated radiation therapy
Radiation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Difference between the target volume to be irradiated as measured by conventional imagining and PET
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Eric Lartigau, MD, PhD
Centre Oscar Lambret
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Centre Oscar Lambret
Lille
59020
France
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx