A Phase 3 Double-Blinded Randomized Study Comparing Personalized Chemotherapy and Radiation Therapy With Standard Chemotherapy and Radiation Therapy in People With HPV-Positive Throat Cancer

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Full Title

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

Purpose

The combination of radiation therapy and chemotherapy (chemoradiation) is a standard treatment for people with HPV-positive throat cancer. HPV is human papillomavirus and can cause throat cancer. Radiation therapy uses radiation to kill cancer cells and shrink tumors. Chemotherapy stops the growth of cancer cells, either by killing the cells or stopping them from dividing. However, this standard combination may cause severe side effects because it is given over 7 weeks. These side effects include sores in the mouth and gut, sore throat, and changes in taste.

In this study, researchers are comparing 7 weeks of standard chemoradiation with a personalized approach of chemoradiation in people with HPV-positive throat cancer. This personalized approach includes a lower dose of chemotherapy and radiation therapy given over only 3 weeks. Researchers will see if 3 weeks of personalized chemoradiation is as effective as the standard 7-week approach. They will also see how it affects side effects and quality of life.

If you join this study, you will be randomly assigned to get either standard chemoradiation or personalized chemoradiation. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have HPV-positive oropharyngeal (throat) cancer that has not spread.
  • Have not received prior radiation or chemotherapy for this throat cancer.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Nancy Lee’s office at 212-639-3341.

Protocol

24-200

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

ClinicalTrials.gov ID

NCT06563479