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

Launched by GROUPE ONCOLOGIE RADIOTHERAPIE TETE ET COU · Feb 28, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment for patients with a specific type of cancer called head and neck squamous cell carcinoma (HNSCC) that has spread to other parts of the body (known as oligometastases). The researchers want to find out if combining a type of targeted radiation therapy called stereotactic radiotherapy with chemotherapy can help patients live longer without a decrease in their quality of life, compared to those receiving only stereotactic radiotherapy. The trial also aims to evaluate the costs associated with these treatments.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of HNSCC. They should have a good performance status, meaning they can carry out daily activities with little to no limitation, and have a life expectancy of at least six months. Participants should have 1 to 3 metastases (tumors that have spread) that meet specific size criteria and can be treated with the radiation therapy being studied. Those who join the trial can expect to receive either the combination treatment or just the radiation therapy, and all participants will be monitored for how well they respond to the treatment and any side effects they may experience.

Gender

ALL

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 \<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.