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

Center Eugene Marquis

Status: Completed

Conditions: Locally Advanced Malignant Neoplasm; Malignant Neoplasm of Head and Neck

Treatments: Device: Positron emission tomography; Radiation: radiochemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02469922

IDRCB : 2013-A01219-36 (Registry Identifier)

2013-JC-ORLK-TEP

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Positron emission tomography

Experimental group

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

Treatment:

Device: Positron emission tomography

Radiation: radiochemotherapy