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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02469922

Acronym

TEmPoRAL

Enrollment

130

Registered

2015-06-12

Start date

2014-06-30

Completion date

2021-01-29

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm of Head and Neck, Locally Advanced Malignant Neoplasm

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

Interventions

DEVICEPositron emission tomography

RADIATIONradiochemotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Locoregional relapse	2 years

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026