{"preliminary_commentary":{"by_channel":{"x_thread":11,"podcast":2,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02215265\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"PATHOS","nct_id":"NCT02215265","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=pathos-nct02215265. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"PATHOS","arms":[{"description":"Group A Patients with tumours which exhibit no adverse histological features. Patients in this group will not receive any adjuvant treatment as per standard of care.","label":"A: No adjuvant treatment","type":"NO_INTERVENTION"},{"description":"Arm B1: postoperative radiotherapy (PORT) at a dose of 60 Gray (Gy) in 30 fractions over 6 weeks.\n\nGroup B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes \\<61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.","label":"B1: Postoperative radiotherapy 60 Gray","type":"ACTIVE_COMPARATOR"},{"description":"Arm B2: Postoperative radiotherapy (PORT) at a dose 50 Gray in 25 fractions over 5 weeks.\n\nGroup B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes \\<61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.","label":"B2: Postoperative radiotherapy 50 Gray","type":"EXPERIMENTAL"},{"description":"Arm C1: postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks with concurrent Cisplatin chemotherapy (POCRT). Cisplatin may be given 3 weekly (100mg/m2 week 1 and week 4 of radiotherapy) or weekly (40mg/m2 weekly during radiotherapy), according to local practice.\n\nGroup C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of \\<1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease","label":"C1: Postoperative radiotherapy 60 Gray with Cisplatin","type":"ACTIVE_COMPARATOR"},{"description":"Arm C2: Postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks without chemotherapy (Test Arm C2).\n\nGroup C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of \\<1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease","label":"C2: Postoperative radiotherapy 60 Gray without chemotherapy","type":"EXPERIMENTAL"}],"collaborators":["UNICANCER","AdventHealth","University of Leipzig","Princess Alexandra Hospital, Brisbane, Australia","Stanford University"],"completion_date":{"date":"2028-04","type":"ESTIMATED"},"conditions":["Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer"],"enrollment":{"count":1269,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Postoperative radiotherapy","otherNames":[],"type":"RADIATION"}],"last_update":"2025-02-19","lead_sponsor":"Lisette Nixon","official_title":"A Phase III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-10","type":"ESTIMATED"},"primary_outcomes":[{"measure":"MDADI/Overall survival co-primary endpoint","timeFrame":"At 12 months following treatment measured using the MD Anderson Dysphagia Inventory (MDADI) score."}],"references":[{"citation":"O'Hara JT, Hurt CN, Ingarfield K, Patterson JM, Hutcheson K, Canham JE, Nixon LS, Heiberg CD, Johson S, Evans M, Jones TM. Transoral Laser or Robotic Surgery Outcomes for Oropharyngeal Carcinoma: Secondary Analysis of the PATHOS Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Oct 10;150(11):1002-11. doi: 10.1001/jamaoto.2024.3371. Online ahead of print.","pmid":"39388196","type":"DERIVED"},{"citation":"Owadally W, Hurt C, Timmins H, Parsons E, Townsend S, Patterson J, Hutcheson K, Powell N, Beasley M, Palaniappan N, Robinson M, Jones TM, Evans M. PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer. BMC Cancer. 2015 Aug 27;15:602. doi: 10.1186/s12885-015-1598-x.","pmid":"26311526","type":"DERIVED"}],"start_date":{"date":"2015-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)","url":"https://clinicaltrials.gov/study/NCT02215265"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/pathos-nct02215265"}