Study on Using Blood Tests to Guide Radiation Therapy for HPV-Positive Head and Neck Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05541016

Provider View

This clinical trial is exploring whether a blood test can help doctors decide the best level of radiation therapy for patients with HPV-positive head and neck cancer. The goal is to balance treatment effectiveness with side effects and to detect cancer recurrence early.

Patient Parameters

Program Overview

This study is testing a blood-based biomarker to help guide treatment decisions for patients with HPV-positive head and neck cancer. The standard treatments include radiation therapy, sometimes combined with chemotherapy or surgery. This study aims to see if a blood test can help doctors choose the right intensity of treatment to reduce side effects while still effectively treating the cancer. The test may also help in early detection of cancer returning and guide further treatment.

Description

Primary Goals:

  1. Use a blood test to help decide the right treatment intensity for patients with HPV-positive head and neck cancer.
  2. Show that patients who usually get radiation after surgery but are at low risk of cancer returning can have good outcomes with less intense treatment.
  3. Show that certain patients can have good outcomes with a specific type of radiation therapy called DART.
  4. Measure how often cancer returns in high-risk patients using the blood test.
  5. Use the blood test during treatment to guide the intensity of radiation therapy.

Secondary Goals:

  1. Compare how long patients live without cancer returning across different treatment groups.
  2. Assess overall survival and patient-reported outcomes.
  3. Evaluate treatment side effects and patterns of cancer recurrence.
  4. Compare functional outcomes and costs of follow-up visits.
  5. Investigate the impact of smoking history on cancer outcomes.

Research Goals:

  1. Study the blood test's ability to predict cancer recurrence.
  2. Analyze saliva samples to see if they can help predict cancer returning.
  3. Compare different methods of detecting cancer recurrence.

Study Groups:

  • Group I: Patients are observed after surgery and undergo regular imaging and blood tests.
  • Group II: Patients receive DART radiation therapy and chemotherapy, with regular imaging and blood tests.
  • Group III: Patients receive standard radiation therapy and possibly chemotherapy, with regular imaging and blood tests.
  • Group IV: Patients receive radiation therapy based on blood test results, with regular imaging and blood tests.

After treatment, patients are followed up regularly for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have confirmed HPV-positive head and neck cancer.
  • Plan for surgery or chemoradiotherapy with cisplatin.
  • No distant cancer spread.
  • Good overall health status.
  • Negative pregnancy test for women of childbearing potential.
  • Willing to provide blood samples and return for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing women.
  • Unwilling to use contraception if of childbearing potential.
  • Severe health conditions that could interfere with the study.
  • Immunocompromised or HIV-positive patients.
  • Uncontrolled illnesses or psychiatric conditions.
  • Receiving other investigational treatments.
  • Other active cancers within the last 5 years, except certain skin or cervical cancers.
  • Previous radiation therapy to the affected area.
  • Severe allergies to study medications.
  • Severe pre-existing hearing or nerve damage.

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