Who is sponsoring NCT05387915?

NCT05387915 is sponsored by Emory University.

What drugs are being tested in NCT05387915?

Interventions in NCT05387915: Radiation Therapy.

Is NCT05387915 still recruiting?

NCT05387915 is currently active, enrolled. Last updated 1 April 2026.

Last reviewed 2026-04-01 · How we verify

NCT05387915

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Biomarker-Driven Radiation Therapy Dose Reduction After Transoral Robotic Surgery for the Treatment of HPV-Positive Oropharyngeal Cancer

Active, enrolled Phase 2 Last updated 1 April 2026

What this trial tests

Phase 2 trial testing Radiation Therapy in Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 in 33 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 June 2022

Primary endpoint
5 January 2026

5 January 2028

Quick facts

Lead sponsor	Emory University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	6 June 2022
Primary completion	5 January 2026
Estimated completion	5 January 2028
Sites	3 locations across United States

Drugs / interventions tested

Radiation Therapy — full drug profile →

Conditions studied

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 — all drugs for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 →
Oropharyngeal HPV-Positive Squamous Cell Carcinoma — all drugs for Oropharyngeal HPV-Positive Squamous Cell Carcinoma →

Sponsor

Emory University

Who can join

18 and older, any sex, with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 or Oropharyngeal HPV-Positive Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard of care treatment for HPV positive oropharyngeal cancer is transoral robotic surgery followed by radiation therapy. However, this treatment is associated with many long-term side effects including difficulty swallowing. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving reduced dose radiation therapy after transoral robotic surgery may improve swallowing outcomes and quality of life compared to standard of care dose radiation therapy after transoral robotic surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The Sinai Robotic Surgery Trial in HPV-related oropharyngeal squamous cell carcinoma (SIRS 2.0 trial) - study protocol for a phase II non-randomized non-inferiority trial.
Chai RL, Ferrandino RM, Barron C, Donboli K, et al · · 2022 · cited 8× · PMID 36091121 · DOI 10.3389/fonc.2022.965578

Verify or expand the search:

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Trials testing the same drug.

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NCT07466316 — A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Ove · Phase 3 · not yet recruiting

Other recruiting trials for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Currently open trials in the same condition.

NCT06532279 — Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patient · Phase 2 · recruiting
NCT06914999 — Comparing an Investigational Scan (F-18 NaF PET/CT) to Standard of Care Imaging (F-18 FDG PET/CT) for Evaluating Vascula · EARLY_PHASE1 · recruiting
NCT06323460 — Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer · Phase 2 · recruiting
NCT05541016 — De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA · Phase 2 · recruiting
NCT04900623 — Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study · Phase 2 · recruiting

Other Emory University trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05387915 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 1 April 2026

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/NCT05387915.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing