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NCT05388773
Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Phase 2 trial testing therapeutic conventional surgery in Oropharynx Cancer in 150 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | Heath Skinner |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 20 July 2022 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- therapeutic conventional surgery
- laboratory biomarker analysis — full drug profile →
- quality-of-life assessment
- intensity-modulated radiation therapy
- Cisplatin (cisplatin) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- Oropharynx Cancer — all drugs for Oropharynx Cancer →
Sponsor
Heath Skinner
Who can join
18 and older, any sex, with Oropharynx Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05388773
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT02270606 — Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer · Phase 1 · completed
- NCT02106559 — Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy · NA · withdrawn
- NCT01918644 — Neoadjuvant SBRT With Concomitant Capecitabine in Resectable Pancreatic Cancer · Phase 1 · completed
Other recruiting trials for Oropharynx Cancer
Currently open trials in the same condition.
- NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
- NCT07063212 — A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC) · Phase 2 · recruiting
- NCT07033091 — Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening · NA · recruiting
- NCT06309225 — Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly · NA · recruiting
- NCT06563362 — Personalized Volume-deescalated Elective Nodal Irradiation in Oropharyngeal Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
Other Heath Skinner trials
Trials by the same sponsor.
- NCT02384434 — Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma · NA · completed
- NCT02057107 — SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05388773 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Heath Skinner
- Last refreshed: 19 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05388773.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing