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Active, not recruiting Phase 2

Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC

NCT03070366 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2015-09-21
Last updated
2026-10-02

Condition(s) studied

Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

ChemotherapyStereotactic radiotherapy

Chemotherapy: * cisplatin * 5FU * carboplatin * cetuximab

Stereotactic radiotherapy: Stereotactic radiotherapy

Study summary

The aim of this study is to evaluate the rate of living patients at 1 year with a quality of life criteria (no decrease) and reduced toxicities. This criteria will be compared in both groups., A cost effectiveness study is scheduled also.

Eligibility

Sex
ALL
Min age
18 Years
Max age
77 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * PS:0-2 * Estimated life expectancy ≥ 6 months * Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck * Target metastases can be treated in stereotactic radiotherapy * 1-3 synchronized metastases with unrestricted anatomic site * Greater cumulative diameter of synchronous metastases in once organ (liver, lung or brain) ≤ 6 cm with GTV = Clinical Target Volume (CTV) * Global maximum diameter (GTV) allowed for pulmonary oligometastases (less than 2 cm from the mediastinum), brain, node, is ≤ 3cm * Implementation of a method for taking into account movements and uncertainties (IGRT) for limiting the margin of CTV to PTV (PTV) so as not to exceed 7 cm large cumulative diameter of PTV * Performing a positron emission tomography with 18F-2-fluoro-2-deoxy-D-glucose (FDG-PET) 4 weeks before the inclusion * In case of cerebral metastases, MRI diagnostic is required * If locoregional disease is treated, controlled and non-progressive for more than three months (+/- 4 weeks) at baseline, synchronized initial tumor is possible * If metachronous metastases, locoregional disease previously treated should be monitored and considered not progressive for more than three months at baseline * In case of prior cancer other than HNSCC, complete remission for over 5 years is possible, any biopsy of metastases is left to the appreciation of referring physician * No chemotherapy or local treatment of metastases in the previous 6 months * Laboratory tests consistent with the achievement of chemotherapy: Leukocytes\> 3,000 / mm3 (including polynuclear\> 2000 / mm3) platelets\> 150,000 / mm3, serum glutamate oxaloacetate transminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphatase, bilirubin \<2.5 upper limit of normal (ULN) * Affiliation to an health insurance * Informed Consent Form signed Exclusion Criteria: * Concomitant participation in other interventional clinical trial within 4 weeks before inclusion * Other prior ablative treatment of targets metastases (surgery, radio frequency) in the previous six months * metachronous primitive tumor (second cancer) uncontrolled. * contraindication to any systemic therapy (chemotherapy and / or targeted therapy) * Known hypersensitivity reaction to 5FU, cisplatin, carboplatin, platin or cetuximab * Active infection (infection requiring IV antibiotics), including active tuberculosis and known and declared human immunodeficiency virus (HIV) * Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix * Individual deprived of liberty by judicial or administrative decision, or under any kind of guardianship * Pregnant or breast feeding women. Every woman who has childbearing potential, must have a negative pregnancy test (serum or urine) within 14 days previous treatment. Patients (men or women) must use a reliable method of contraception throughout treatment and for at least 6 months after discontinuation of chemotherapy.

Primary outcome measure(s)

  • Overall Survival without quality of life deterioration — 1 year
    Overall Survival rate without definitive deterioration of quality of life (by QLQC30) measured at 1 year post treatment

Trial sites (1)

FacilityCityRegionStatus
Hôpital Nord Franche Comté Montbéliard France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03070366 on ClinicalTrials.gov ↗ ← All trials in France