Study on Reducing Treatment Intensity for Favorable Risk HPV-Positive Throat Cancer

Sponsor: NYU Langone Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03215719

Provider View

This clinical trial is exploring whether it's possible to safely reduce the intensity of chemoradiation treatment for patients with HPV-positive throat cancer, based on how well the tumor responds during treatment. The main goal is to see if patients remain cancer-free for two years.

Patient Parameters

Program Overview

This study aims to find out if it's feasible to lower the intensity of chemoradiation treatment for patients with HPV-positive throat cancer, depending on how the tumor shrinks during treatment. Researchers will monitor patients to see if they stay cancer-free for two years. They will also look at how well the cancer is controlled in the throat area, overall survival rates, quality of life, and any long-term side effects. Patients will complete a questionnaire about their quality of life, and any side effects will be assessed using standard criteria. The study will also evaluate the significance of HPV presence in saliva and blood at different stages of treatment, and analyze pre-treatment imaging to see how it relates to outcomes.

Description

The study will also focus on several secondary goals, such as controlling cancer in the throat area and overall survival rates over two years. Researchers will assess quality of life using a questionnaire that patients fill out themselves. They will also monitor any long-term side effects using standard criteria. Additionally, the study will look at the importance of detecting HPV in saliva and blood at different times during and after treatment, starting with a baseline evaluation before treatment begins. Researchers will also analyze pre-treatment imaging to see how it relates to patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oropharynx (throat), including tonsil, base of tongue, soft palate, or back of the throat.
  • Tumor tissue must test positive for p16, a marker associated with HPV, using a specific lab test.
  • Detectable HPV DNA in the blood at the start of the study.
  • Cancer stage T1-T2, N1-N2b or T3, N1-N2b, with no spread to distant parts of the body.
  • Undergo specific imaging tests within 8 weeks before joining the study.
  • Provide a personal smoking history, with a limit of 10 pack-years.
  • Good overall health with a performance status score of 0 or 1.
  • Adequate blood cell counts and organ function based on recent tests.
  • Negative pregnancy test for women of childbearing potential.
  • HIV-positive patients can participate if they meet certain health criteria.
  • Must not have hepatitis B or C, unless immune to hepatitis B.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Cancers originating from the mouth, nasopharynx, hypopharynx, or larynx.
  • Unknown primary site of cancer in the neck.
  • Cancer spread to distant parts of the body or below the collarbones.
  • Complete removal of both primary and nodal disease through surgery.
  • Multiple primary cancers or cancer in both sides of the throat.
  • Previous invasive cancer unless disease-free for at least 3 years.
  • Previous chemotherapy for the study cancer.
  • Previous radiation therapy that overlaps with the study area.
  • Severe active health conditions, such as recent heart issues or infections.
  • Pregnancy or breastfeeding.
  • Allergic reaction to cisplatin.
  • Conditions that prevent MRI scans, such as certain implants or claustrophobia.
  • Severe kidney issues preventing certain MRI scans.

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