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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