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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2021-01-29

Brief Summary

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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

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Detailed Description

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Conditions

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Malignant Neoplasm of Head and Neck Locally Advanced Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Positron emission tomography

Intervention Type DEVICE

radiochemotherapy

Intervention Type RADIATION

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

Interventions

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Positron emission tomography

Intervention Type DEVICE

radiochemotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No