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

Sponsored by:	Centre Oscar Lambret
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00809016

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	Drug: fludeoxyglucose F 18 Procedure: 3-dimensional conformal radiation therapy Procedure: intensity-modulated radiation therapy

MedlinePlus related topics: Cancer Head and Neck Cancer Nuclear Scans Salivary Gland Disorders Tonsils and Adenoids

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label
Official Title:	Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-Modulated Radiotherapy of Ear, Nose and Throat Tumors

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 [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809016

Locations

France
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: Eric Lartigau, MD, PhD 33-3-2029-5911 e-lartigau@o-lambret.fr

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

Investigator:

Eric Lartigau, MD, PhD

Centre Oscar Lambret

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000626776, COL-0606, COL-TEPORL, COL-RCB 2007-A00291-52, INCA-RECF0488
Study First Received:	December 13, 2008
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00809016
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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
stage III lymphoepithelioma of the oropharynx

Study placed in the following topic categories:

Squamous cell carcinoma
Carcinoma, Basal Cell
Adenoid cystic carcinoma
Dental Caries
Recurrence
Carcinoma
Epidermoid carcinoma
Carcinoma, Adenoid Cystic

Metastatic squamous neck cancer with occult primary
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Adenocarcinoma
Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009