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Completed

NCT Number: NCT02469922

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

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

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Key information

Conditions

Malignant Neoplasm of Head and Neck Head and Neck Neoplasms Locally Advanced Malignant Neoplasm Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron emission tomography

Device

Radiochemotherapy

Radiation

Every patients will be treated with radiochemotherapy as a standard of care

Primary outcomes

  1. Locoregional relapse

    Time frame: 2 years

Secondary outcomes

  1. Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)

    Time frame: pretreatment, 15 days, 29 days, 3 months post treatment

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

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

Acronym: TEmPoRAL

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2015
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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