RecruitingPhase 3NCT06563479

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

291 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a personalized, lower-dose radiation therapy approach to standard radiation for people with HPV-related throat cancer. Because HPV-associated throat cancers tend to respond better to treatment, researchers want to see if reducing the radiation dose maintains effectiveness while causing fewer side effects. **You may be eligible if...** - You have been diagnosed with HPV-positive squamous cell carcinoma of the oropharynx (tonsils, base of tongue, or throat walls), or a squamous cell cancer with unknown primary site - Your cancer is at an early to intermediate stage with no distant spread - You are age 18 or older - You are in good general health (ECOG 0–1 or KPS ≥70) - You have adequate blood counts and kidney function **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have significant kidney problems or very low blood counts - You are pregnant - Your cancer is HPV-negative Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTFMISO-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_PRODUCTChemoradiation

30 Gy or 70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU)

COMBINATION_PRODUCTChemoradiation

70 Gy of radiation in combination with standard chemotherapy (cisplatin, carboplatin, and 5-FU)

OTHERAssessments

EQ-5D-5L (5 questions); 2. MDADI-HN (total of 20 questions); 3. COST-FACIT (total of 12 questions).


Locations(9)

Hartford Healthcare (Data Collection Only)

Hartford, Connecticut, United States

Baptist Alliance MCI (Data Collection Only)

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06563479


Related Trials