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

Not Applicable

Completed

• Conditions: Malignant Neoplasm of Head and Neck; Locally Advanced Malignant Neoplasm
• Interventions: Device: Positron emission tomography; Radiation: radiochemotherapy

• Registration Number: NCT02469922
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Status Verified: 2020-07
• Primary Completion: 2021-01-29
• Study Completion: 2021-01-29
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positron emission tomography	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
Positron emission tomography	radiochemotherapy	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

Primary Outcome Measures

Name	Time	Method
Locoregional relapse	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Centre jean Bernard - Rue Victor Hugo; 🇫🇷 Le Mans, France

CHU Brest; 🇫🇷 Brest, France

Hôpital du Scorff; 🇫🇷 Lorient, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre d'Oncologie St Vincent - Boulevard de la Boutière; 🇫🇷 Saint Grégoire, France