Positron Emission Tomography (PET) During Radio-chemotherapy to Treat Otorhinolaryngological Cancer
Overview
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
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: January 29, 2021
Interventions
- Device: Positron emission tomography
- Radiation: radiochemotherapy
- Every patients will be treated with radiochemotherapy as a standard of care
Arms, Groups and Cohorts
- Experimental: Positron emission tomography
- 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
Clinical Trial Outcome Measures
Primary Measures
- Locoregional relapse
- Time Frame: 2 years
Secondary Measures
- Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)
- Time Frame: pretreatment, 15 days, 29 days, 3 months post treatment
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Center Eugene Marquis
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Castelli Joël, Doctor, Principal Investigator, Centre de Lutte Contre le Cancer Centre Eugène Marquis
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