{"preliminary_commentary":{"by_channel":{"x_thread":3,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[],"indication":"head and neck squamous cell carcinoma with oligometastases","name":"GORTEC 2014-04","nct_id":"NCT03070366","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=gortec-2014-04-nct03070366. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"OMET","arms":[{"description":"Chemotherapy is based on patient Performance Status (PS) and comorbidities:\n\n* PS 0-1: standard treatment: 6 cycles, every 3 weeks cisplatin (100 mg/m² iv on D1), 5FU (4000 mg/m² total dose starting on Day 1 to Day 4 and during 96h in continuous infusion)\n* PS 2/cardiac contra-indication to 5 Fluorouracil (5FU): 6 cycles, every 3-4 weeks cisplatin (100 mg/m² iv on Day 1) or carboplatin Area Under Curve (AUC) 4 or 5 on Day 1 In both case: Cetuximab (loading dose 400 mg/m² iv on Day1, then 250 mg/m² weekly or 500mg/m² every 2 weeks).\n\nCycle 1 of systemic treatment will be administered before the start of the stereotactic RT. Then, following cycles will be performed after the end of stereotactic irradiation.\n\nCetuximab maintenance: 250 mg/m² iv weekly. It will be given only if at least disease stabilization is observed at the end of chemotherapy, and will be continued until progression or unacceptable toxicity.","label":"Chemotherapy combined with stereotactic radiotherapy (RT)","type":"ACTIVE_COMPARATOR"},{"description":"Splitting will be based on the tumor diameter, and proximity of organs at risk which constitutes any limiting toxicities. It will be 3 or 5 fractions based on the recommendations (CARO-Stereotactic Body Radiation Therapy (SBRT) 2012) and for the purpose of harmonization practices. The prescription dose is 3 x 10 = 30 Gy 3 x 11 = 33 Gy or 3 x 15 = 45 Gy (if 3 fractions) with the possibility of 3 x 20 Gy to the peripheral lung nodules with tracking in Cyberknife or 5 x 7 = 35 Gy or 5 Gy x 10 = 50 (if 5 fractions). Beyond 3 cm of tumor diameter and / or to a distance of less than 1 cm from the GTV in an organ critical risk (eg spinal cord), a splitting up into 5 sessions must be privileged.","label":"stereotactic radiotherapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-12","type":"ESTIMATED"},"conditions":["Head and Neck Squamous Cell Carcinoma"],"enrollment":{"count":78,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Chemotherapy","otherNames":[],"type":"DRUG"},{"name":"Stereotactic radiotherapy","otherNames":[],"type":"RADIATION"}],"last_update":"2026-10-02","lead_sponsor":"Groupe Oncologie Radiotherapie Tete et Cou","official_title":"Randomized Phase II Trial Comparing Chemotherapy Combined With Stereotactic Radiotherapy and Stereotactic Radiotherapy Alone, for Treatment of Oligometastases in Squamous Cell Cancers of the Upper Aerodigestive Tract","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall Survival without quality of life deterioration","timeFrame":"1 year"}],"references":[],"start_date":{"date":"2015-09-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC","url":"https://clinicaltrials.gov/study/NCT03070366"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/gortec-2014-04-nct03070366"}