NCT06563479

A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer

Phase III Randomized and Double-blinded Trial of De-escalated Radiation in FMISO PET-selected Good Risk Versus Standard of Care Radiation in Unselected HPV Positive Oropharyngeal Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 291 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: * Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy * How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires.

Conditions

• HPV-Related Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FMISO-PET Scan	Patients will undergo 18F-FMISO scan (only 1 injection) that occurs at week two of radiation treatment, typically day 10 but a window of 8-10 radiation treatment days\* after start of radiation is allowed.
COMBINATION_PRODUCT	Chemoradiation	30 Gy or 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU)
COMBINATION_PRODUCT	Chemoradiation	70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU)
OTHER	Assessments	EQ-5D-5L (5 questions); 2. MDADI-HN (total of 20 questions); 3. COST-FACIT (total of 12 questions).

Timeline

• Start date: 2024-08-19
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2024-08-20
• Last updated: 2026-02-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study