A Study Assessing Cell-Free Tumor DNA Testing to Decide When to Start Routine Treatment in People with Human Papilloma Virus (HPV)-Associated Oropharynx Cancer

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Full Title

A Pilot Study Evaluating Selective Minimal Residual Disease Directed Adjuvant Radiation in Human Papilloma Virus Associated Oropharynx Carcinoma

Purpose

The usual approach to managing HPV-related oropharynx cancer in people whose tumors have a higher risk of coming back after surgery is to use radiation therapy to prevent tumor relapse. However, not all patients have tumors that come back after surgery, and many may not need radiation therapy at all, or only need it later when there are early signs of the cancer coming back.

Researchers think that one useful way to monitor people for cancer relapse is to check levels of HPV cell-free tumor DNA (ctDNA) in the blood. ctDNA is genetic material from a very small number of cancer cells remaining in the body during or after treatment. Investigators are doing this study to see if monitoring HPV ctDNA levels can safely identify patients who do not need radiation therapy right after surgery and whose radiation therapy can be delayed until HPV ctDNA levels become detectable. Participants will receive routine radiation therapy if their HPV ctDNA levels rise after surgery.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have HPV-related oropharynx squamous cell carcinoma that can be surgically removed or was recently surgically removed.  
  • Prior chemotherapy for oropharynx cancer or radiation therapy to the head and neck is not permitted.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Linda Chen at 201-775-7447

Protocol

21-434

Phase

Pilot (small research study)

Investigator