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

Locally Advanced Malignant Neoplasm Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469922
• Other study ID #: 2013-JC-ORLK-TEP
• Secondary ID: IDRCB : 2013-A01
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: January 29, 2021

Study information

• Verified date: July 2020
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Locally Advanced Malignant Neoplasm
• Malignant Neoplasm of Head and Neck
• Neoplasms

Intervention

Device:
• Positron emission tomography

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

Locations

Country	Name	City	State
France	CHU Brest	Brest
France	Centre jean Bernard - Rue Victor Hugo	Le Mans
France	Hôpital du Scorff	Lorient
France	Centre Eugene Marquis	Rennes
France	Centre d'Oncologie St Vincent - Boulevard de la Boutière	Saint Grégoire

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional relapse		2 years
Secondary	Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)		pretreatment, 15 days, 29 days, 3 months post treatment