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

July 26, 2021 updated by: Center Eugene Marquis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • CHU Brest
      • Le Mans, France, 72015
        • Centre jean Bernard - Rue Victor Hugo
      • Lorient, France
        • Hôpital du Scorff
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Saint Grégoire, France, 35460
        • Centre d'Oncologie St Vincent - Boulevard de la Boutière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Positron emission tomography
Radiation: radiochemotherapy
Every patients will be treated with radiochemotherapy as a standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Locoregional relapse
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Castelli Joël, Doctor, Centre de Lutte Contre le Cancer Centre Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

January 29, 2021

Study Completion (Actual)

January 29, 2021

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-JC-ORLK-TEP
  • IDRCB : 2013-A01219-36 (Registry Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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