Positron Emission Tomography (PET) During Radio-chemotherapy to Treat Otorhinolaryngological Cancer

Study Overview
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Brief Summary
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Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years

Official Title
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Prospective Study Assessing Predictive Value of 18 F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography During Radio-chemotherapy for Locally Advanced Epidermoid Carcinoma of Head and Neck

Conditions
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Malignant Neoplasm of Head and Neck, Locally Advanced Malignant Neoplasm

Intervention / Treatment
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* Device: Positron emission tomography
* Radiation: radiochemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and ≤ 75 years invasive epidermoid carcinoma of head and neck (excluding nasopharyngeal), confirmed by histology locally advanced disease (non-metastatic stages AJCC III-IV). AJCC = American Joint Committee on Cancer performance status ECOG ≤ 2. ECOG = Eastern Cooperative Oncology Group no history of irradiation of the head and neck start of radiotherapy within 8 weeks after the pretreatment PET Scan no surgery other than biopsy pregnancy test: negative for women of childbearing potential reliable contraception for a childbearing couple, men and woman must have a reliable contraception during treatment signed informed consent form patient with national health insurance Exclusion Criteria: prior radiotherapy or chemotherapy history of other cancer except: cutaneous non-melanoma tumor and cervix in situ carcinoma unstable conditions (cardiovascular, renal, pulmonary) or systemic (lupus erythematosus, scleroderma) pregnant patient or patient with breastfeeding patient unable to give his consent patient under administrative supervision patient who participates to another clinical trial on experimental drug regular follow-up impossible for various reasons (familial, economical, social, ...) diabetes accelerated radiotherapy protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positron emission tomography<br>Two additional PET Scan will be performed at 2 and 4 weeks for the first 30 patients. Then for the other patients only one additional PET-Scan will be performed | Device: Positron emission tomography<br> <br> Radiation: radiochemotherapy<br>* Every patients will be treated with radiochemotherapy as a standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional relapse |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume) |  | pretreatment, 15 days, 29 days, 3 months post treatment |