Study Comparing Personalized Radiation Therapy with Standard Radiation Therapy for HPV-Positive Throat Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06563479

Provider View

This clinical trial is exploring whether a personalized approach to radiation therapy, which may involve a lower dose, is as effective as the standard treatment for people with HPV-positive throat cancer. The study also examines if the lower dose causes fewer side effects and how it impacts participants' quality of life.

Patient Parameters

Program Overview

The purpose of this study is to determine if a personalized approach to chemoradiation therapy, which might include a lower dose of radiation, is as effective as the standard treatment for people with HPV-positive throat cancer. Researchers are also looking at whether the lower dose of radiation combined with standard chemotherapy results in fewer side effects compared to the standard dose. Additionally, the study will assess how these treatment approaches affect participants' quality of life by having them fill out questionnaires.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HPV-positive squamous cell carcinoma of the throat, including tonsil, base of tongue, or throat walls, or squamous cell carcinoma with an unknown primary site. Surgery to remove the primary site is allowed.
  • Must test positive for specific markers (p16 expression and mRNA HPV) using approved testing methods.
  • Cancer must be at a specific stage (T0-2, N1-2c) without signs of spreading to distant parts of the body.
  • Must have a performance status score indicating good overall health (ECOG 0-1 or KPS ≥70).
  • Must be 18 years or older.
  • Must have adequate blood cell counts and kidney function based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Previous radiation therapy to the head and neck that overlaps significantly with the current treatment area, unless approved by the study leaders.
  • Tumors that are borderline advanced (T4) due to their location.
  • Having another primary cancer outside the throat area, unless approved by the study leaders.
  • History of another invasive cancer unless disease-free for 3 years or with a high cure rate.
  • Previous chemotherapy for the throat cancer being studied; chemotherapy for other cancers is allowed.
  • Cannot have had particle therapy.
  • Unable to comply with all study-related activities.
  • Cannot receive certain chemotherapy drugs (cisplatin or carboplatin/5-fluorouracil) at the required doses.
  • Severe health conditions such as recent heart problems, serious infections, or liver issues.

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