Clinical trial · Interventional
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
NCT02469922CI-TRIAL-00052915TEmPoRALcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Malignant Neoplasm of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positron emission tomography | Device | — | UNRESOLVED |
| radiochemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Positron emission tomography
- 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
- interventionNames
- Device: Positron emission tomography
- Radiation: radiochemotherapy
Primary outcomes (1)
- measure
- Locoregional relapse
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)
- timeFrame
- pretreatment, 15 days, 29 days, 3 months post treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.