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

Primary Purpose

Malignant Neoplasm of Head and Neck, Locally Advanced Malignant Neoplasm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positron emission tomography
radiochemotherapy
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Neoplasm of Head and Neck

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Brest
  • Centre jean Bernard - Rue Victor Hugo
  • Hôpital du Scorff
  • Centre Eugene Marquis
  • Centre d'Oncologie St Vincent - Boulevard de la Boutière

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positron emission tomography

Arm Description

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

Outcomes

Primary Outcome Measures

Locoregional relapse

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2014
Last Updated
July 26, 2021
Sponsor
Center Eugene Marquis
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1. Study Identification

Unique Protocol Identification Number
NCT02469922
Brief Title
Positron Emission Tomography (PET) During Radio-chemotherapy to Treat Otorhinolaryngological Cancer
Acronym
TEmPoRAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
January 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Head and Neck, Locally Advanced Malignant Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positron emission tomography
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Positron emission tomography
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy
Intervention Description
Every patients will be treated with radiochemotherapy as a standard of care
Primary Outcome Measure Information:
Title
Locoregional relapse
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)
Time Frame
pretreatment, 15 days, 29 days, 3 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Castelli Joël, Doctor
Organizational Affiliation
Centre de Lutte Contre le Cancer Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brest
City
Brest
Country
France
Facility Name
Centre jean Bernard - Rue Victor Hugo
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Hôpital du Scorff
City
Lorient
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre d'Oncologie St Vincent - Boulevard de la Boutière
City
Saint Grégoire
ZIP/Postal Code
35460
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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