Testing Less Intensive Radiation with Chemotherapy for Low-Risk Patients with HPV-Positive Throat Cancer

Sponsor: University of Missouri-Columbia

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04444869

Provider View

This clinical trial is exploring whether using lower doses of radiation therapy, along with standard chemotherapy, can effectively treat HPV-positive throat cancer while reducing long-term side effects and improving quality of life.

Patient Parameters

Program Overview

The trial aims to find out if giving lower doses of radiation to lymph nodes not affected by HPV-positive throat cancer can still control the disease effectively. Researchers hope this approach will reduce long-term side effects and improve the quality of life for patients who live well beyond their cancer treatment.

Description

This study focuses on patients with HPV-positive throat cancer, which is known to respond well to radiation. The goal is to see if using less radiation on unaffected lymph nodes can still control the cancer without increasing side effects. Patients with this type of cancer usually have good outcomes, but long-term side effects from treatment can affect their quality of life. By reducing radiation doses, the study hopes to maintain effective cancer control while minimizing side effects like dry mouth and difficulty swallowing. The trial will test if this approach is safe and improves long-term quality of life without affecting survival rates.

Eligibility Criteria

Inclusion Criteria

  • Must be in good health and able to complete the study requirements.
  • Women and men who are sexually active must use effective birth control during treatment and for 60 days after.
  • Must have a confirmed diagnosis of HPV-positive throat cancer.
  • Must have measurable cancer at the primary site or lymph nodes.
  • Must have a specific protein marker (p16) present in the cancer tissue.
  • Cancer must be at a certain stage (T1-T3, N0-N2c) with no distant spread.
  • Must have a history and physical exam, throat exam, and specific imaging tests before joining the study.
  • Must not be a heavy smoker (more than 10 pack years) unless they quit before starting radiation.
  • Must have a performance status of 0-1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Must have adequate blood, kidney, and liver function based on specific tests.
  • Women of childbearing potential must have a negative pregnancy test before joining.

Exclusion Criteria

  • Cancer from other areas like the mouth, nasopharynx, or larynx, even if HPV-positive.
  • Unknown primary cancer in the neck, even if HPV-positive.
  • Certain small cancers of the tonsil.
  • Large matted lymph nodes or advanced disease.
  • Cancer spread below the collarbone.
  • Complete removal of both primary and nodal disease.
  • Multiple primary cancers or cancer on both sides of the throat.
  • Previous invasive cancer unless disease-free for 5 years.
  • Previous chemotherapy for this cancer.
  • Previous radiation that overlaps with the study area.
  • Severe health conditions like recent heart attack, severe infections, or liver problems.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.