NCT07497607

Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma

Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Sara Medek · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.

Detailed description

The purpose of this research is to determine if a decrease in the dose of radiation to regions which have no visible cancer will be as effective as the standard dose. The dose to all visible cancer remains unchanged to the standard radiation approach. The researchers believe that a lower dose could be just as helpful for treatment, while reducing the side effects of radiation and improving quality of life. The current standard care treatment for OPSCC can have debilitating side effects. Using a decreased dose of 30 Gy from 46-54 Gy to regions without visible cancer but which have a risk of microscopic cancer might be just as effective for treating cancer with less side effects. The combination of these approaches is not considered the current standard of care. Patients will continue to receive standard systemic therapy of cisplatin during radiation therapy.

Conditions

• Oropharyngeal Squamous Cell Carcinoma
• HPV Positive Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Subjects will continue to receive standard systemic therapy of cisplatin during radiation therapy. Weekly SOC Cisplatin at a dose of 40mg/m2 or every 3-week dosing of 100mg/m2 will be administered per institutional guidelines during radiation therapy. The first cisplatin infusion should be initiated during the window from 24 hours before, to 48 hours after the first scheduled radiation treatment. Skipped cisplatin infusions should not be made up, and the last cisplatin infusion should be no later than 7 days after the last fraction of radiation.
RADIATION	Radiotherapy	Radiotherapy will involve a sequential boost approach. Treatment will begin with coverage of the primary site and elective nodal regions to 30 Gy, after which treatment volumes will be reduced to primary site and involved nodes only with PTV margin to 70 Gy.

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-06-01
• Completion: 2036-06-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study