{"preliminary_commentary":{"by_channel":{"x_thread":14,"youtube":3,"podcast":2},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01898494\", \"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."},"commentary_summary":null,"name":"E3311","nct_id":"NCT01898494","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=e3311-nct01898494. 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":null,"arms":[{"description":"Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.","label":"Arm S (Surgery) then Arm A (Low risk, observation)","type":"EXPERIMENTAL"},{"description":"Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.","label":"Arm S (Surgery) then Arm B (Intermediate risk, low-dose IMRT)","type":"EXPERIMENTAL"},{"description":"Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.","label":"Arm S (Surgery) then Arm C (Intermediate risk, standard-dose IMRT)","type":"EXPERIMENTAL"},{"description":"Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.","label":"Arm S (Surgery) then Arm D (High risk, IMRT, chemotherapy)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2026-12","type":"ESTIMATED"},"conditions":["Human Papilloma Virus Infection","Stage III Squamous Cell Carcinoma of the Oropharynx","Stage IVA Squamous Cell Carcinoma of the Oropharynx","Stage IVB Squamous Cell Carcinoma of the Oropharynx"],"enrollment":{"count":519,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Transoral surgery","otherNames":["TOS"],"type":"PROCEDURE"},{"name":"intensity-modulated radiation therapy","otherNames":["IMRT"],"type":"RADIATION"},{"name":"cisplatin","otherNames":["Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II)","diaminedichloroplatinum","cis-platinum","CDDP","DDP","platinum","Platinol","Platinol-AQ","DACP","NSC 119875 R R"],"type":"DRUG"},{"name":"carboplatin","otherNames":["CBDCA","JM-8","NSC-241240","Paraplatin"],"type":"DRUG"}],"last_update":"2026-04-01","lead_sponsor":"ECOG-ACRIN Cancer Research Group","official_title":"Phase II Randomized Trial of Transoral Surgical Resection Followed by Low-Dose or Standard-Dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2020-11-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival Rate at 2 Years","timeFrame":"Assessed every 3 months for 2 years"},{"measure":"Proportion of Patients With Grade III or IV Oropharyngeal Bleeding or Positive Margins","timeFrame":"Assessed during surgery and directly after surgery"}],"references":[{"citation":"Ferris RL, Flamand Y, Weinstein GS, Li S, Quon H, Mehra R, Garcia JJ, Chung CH, Gillison ML, Duvvuri U, O'Malley BW Jr, Ozer E, Thomas GR, Koch WM, Gross ND, Bell RB, Saba NF, Lango M, Mendez E, Burtness B. Phase II Randomized Trial of Transoral Surgery and Low-Dose Intensity Modulated Radiation Therapy in Resectable p16+ Locally Advanced Oropharynx Cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311). J Clin Oncol. 2022 Jan 10;40(2):138-149. doi: 10.1200/JCO.21.01752. Epub 2021 Oct 26.","pmid":"34699271","type":"RESULT"},{"citation":"Burtness B, Flamand Y, Quon H, Weinstein GS, Mehra R, Garcia JJ, Kim S, O'Malley BW Jr, Ozer E, Ikpeazu C, Koch WM, Gross ND, Bell RB, Patel M, Lango MN, Morris LG, Smith R, Karakla D, Richmon JD, Holsinger FC, Ferris RL. Long-Term Follow-Up of E3311, an ECOG-ACRIN Cancer Research Group Phase II Trial of Transoral Surgery and Risk-Based Adjuvant Treatment in Human Papillomavirus-Initiated Oropharynx Cancer. J Clin Oncol. 2025 Aug 10;43(23):2559-2565. doi: 10.1200/JCO-24-02550. Epub 2025 Jun 10.","pmid":"40493877","type":"DERIVED"}],"start_date":{"date":"2014-01-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer","url":"https://clinicaltrials.gov/study/NCT01898494"},"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/e3311-nct01898494"}