NCT05387915

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

Biomarker-Driven Radiation Dose Reduction After TORS in Patients With HPV-Positive Oropharyngeal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate swallow function among post-operative circulating tumor HPV deoxyribonucleic acid (ctHPVDNA)-negative patients treated with reduced intensity adjuvant radiation therapy (RT) doses as compared to historical controls from ECOG 3311. SECONDARY OBJECTIVES: I. Evaluate progression free survival (PFS), overall survival (OS), and locoreginal control (LRC) among post-operative ctHPVDNA-negative patients treated with reduced adjuvant RT doses. II. Evaluate PFS among post-operative ctHPVDNA-positive patients treated with standard of care adjuvant therapy. OUTLINE: Patients who are ctHPVDNA negative after surgery undergo reduced dose radiation therapy for 3 weeks (15 treatments). Patients who are ctHPVDNA positive after surgery undergo standard of care radiation therapy. After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months.

Conditions

• Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Oropharyngeal HPV-Positive Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Undergo reduced dose radiation therapy

Timeline

• Start date: 2022-06-06
• Primary completion: 2026-01-05
• Completion: 2028-01-05
• First posted: 2022-05-24
• Last updated: 2026-04-01

Locations

3 sites across 1 country: United States