Study on Using Lower Dose Radiation Guided by Blood Tests for HPV-Related Throat Cancer

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06323460

Provider View

This clinical trial is exploring whether using a blood test to guide lower dose radiation therapy can effectively treat patients with HPV-related throat cancer. The study compares the effects of this approach with the standard radiation dose combined with chemotherapy.

Patient Parameters

Program Overview

This study is testing a new approach to treating HPV-related throat cancer by using a blood test to guide the amount of radiation therapy given. The blood test detects HPV particles, and if these particles decrease significantly, patients may receive a lower dose of radiation. The goal is to see if this method can effectively treat the cancer while potentially reducing side effects compared to the usual higher dose of radiation combined with chemotherapy.

Description

The main goal of this study is to see how well patients respond to treatment three months after it ends, especially those whose blood tests show a significant drop in HPV particles. Researchers will also look at how long patients stay cancer-free over two years and any side effects from the lower dose treatment.

Patients will receive radiation therapy and chemotherapy. A blood test will be done in the fourth week to check for HPV particles. Based on the results, patients will be divided into two groups:

  • Group 1: Patients with a significant drop in HPV particles will receive a lower dose of radiation for five weeks, along with chemotherapy. They will have regular scans and blood tests.
  • Group 2: Patients without a significant drop in HPV particles will receive the standard dose of radiation for seven weeks, along with chemotherapy. They will also have regular scans and blood tests.

After treatment, patients will have follow-up visits every three months for up to two years to monitor their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with a specific type of throat cancer related to HPV.
  • Positive for a marker called P16 in cancer cells.
  • Cancer must be at a certain stage and not have spread to distant parts of the body.
  • Must have measurable cancer at the primary site or lymph nodes.
  • Must have a specific level of HPV particles in the blood before starting treatment.
  • Must have a smoking history of 10 pack years or less.
  • Must be in good general health with a performance status of 0-2.
  • Must be 18 years or older.
  • Must have adequate blood counts and organ function based on specific tests.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Patients with hepatitis B or C must have controlled or cured infections.
  • Women of childbearing potential must have a negative pregnancy test.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Cancer has returned or spread to distant parts of the body.
  • Cancer originates from the oral cavity, even if HPV-related.
  • Have another primary cancer, except for certain cases like bilateral tonsil cancer.
  • Have had another invasive cancer within the last three years.
  • Have had prior chemotherapy or immunotherapy.
  • Have had prior radiation that overlaps with the study treatment.
  • Have severe heart conditions or require systemic steroids or immunosuppressive medications.
  • Have active autoimmune diseases requiring treatment.
  • Are pregnant, nursing, or planning to have children.
  • Are allergic to the chemotherapy drugs used in the study.

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