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Active Not Recruiting
NCT03070366
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
Conditions: Head and Neck Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – 77 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 78
Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Location: Hôpital Nord Franche Comté Montbéliard
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT03070366). StuddyBuddy aggregates publicly available trial information.