Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
Contribution of Positron Emission Tomography in Biological Targeting by Conformational Radiotherapy and Intensity-modulated Radiotherapy of Ear, Nose and Throat Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Difference between the target volume to be irradiated as measured by conventional imagining and PET
Safety Issue:
No
Principal Investigator
Eric Lartigau, MD, PhD
Investigator Affiliation:
Centre Oscar Lambret
Authority:
United States: Federal Government
Study ID:
CDR0000626776
NCT ID:
NCT00809016
Start Date:
May 2007
Completion Date:
Related Keywords:
- Head and Neck Cancer
- 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
- stage III squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- high-grade salivary gland mucoepidermoid carcinoma
- low-grade salivary gland mucoepidermoid carcinoma
- recurrent salivary gland cancer
- salivary gland acinic cell tumor
- salivary gland adenocarcinoma
- salivary gland adenoid cystic carcinoma
- salivary gland anaplastic carcinoma
- salivary gland malignant mixed cell type tumor
- salivary gland poorly differentiated carcinoma
- salivary gland squamous cell carcinoma
- stage III salivary gland cancer
- stage IV salivary gland cancer
- Head and Neck Neoplasms
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