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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

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 <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.