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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469922
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Head and Neck Locally Advanced Malignant Neoplasm Device: Positron emission tomography Radiation: radiochemotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : June 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

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




Primary Outcome Measures :
  1. Locoregional relapse [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume) [ Time Frame: pretreatment, 15 days, 29 days, 3 months post treatment ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469922


Locations
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France
CHU Brest
Brest, France
Centre jean Bernard - Rue Victor Hugo
Le Mans, France, 72015
Hôpital du Scorff
Lorient, France
Centre Eugene Marquis
Rennes, France, 35042
Centre d'Oncologie St Vincent - Boulevard de la Boutière
Saint Grégoire, France, 35460
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Principal Investigator: Castelli Joël, Doctor Centre de Lutte Contre le Cancer Centre Eugène Marquis
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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT02469922    
Other Study ID Numbers: 2013-JC-ORLK-TEP
IDRCB : 2013-A01219-36 ( Registry Identifier: ANSM )
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Neoplasms
Head and Neck Neoplasms
Neoplasms by Site