Study on Lowering Radiation Dose to the Neck for Treating HPV-Related Throat Cancer (ENLIGHT Trial)

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07178301

Provider View

This clinical trial is exploring whether reducing the radiation dose to certain neck areas can still effectively treat HPV-related throat cancer while minimizing side effects. The study aims to maintain high cure rates and improve patients' quality of life by lowering radiation exposure to lymph nodes not directly affected by cancer.

Patient Parameters

Program Overview

This study is testing if lowering the radiation dose to the neck's lymph nodes, which are not directly involved in HPV-related throat cancer, can still effectively treat the cancer while reducing side effects. Radiation therapy is crucial in treating this type of cancer but can cause significant side effects. By reducing radiation to these areas, researchers hope to maintain excellent treatment outcomes and improve patients' quality of life.

Description

PRIMARY OBJECTIVE:

  • To find out if the cancer stays under control in the neck area for two years after treatment.

SECONDARY OBJECTIVES:

  • To see if the cancer stays under control overall for two years.
  • To check if cancer returns in the neck area that received a lower radiation dose within two years.
  • To measure overall survival rates for two years.
  • To track doctor-reported side effects at 1, 3, and 12 months using standard criteria.
  • To assess patient-reported side effects at 1, 3, and 12 months using a specific questionnaire for head and neck cancer patients.

OUTLINE:

Patients will receive standard radiation therapy to the tumor and a lower dose to the neck's lymph nodes five days a week for seven weeks. They will also have CT, PET scans, and throat exams during the trial. After treatment, patients will have follow-up visits every three months for two years.

Eligibility Criteria

Inclusion Criteria

  • Must have HPV-related throat cancer confirmed by specific lab tests.
  • Must not have had any prior treatment for this cancer.
  • Must have cancer that can be measured by standard criteria.
  • Must be 18 years or older.
  • Must have stage I-II cancer according to specific medical guidelines, with no spread to other body parts.
  • Must have a PET scan before joining the study.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • May receive radiation alone or with chemotherapy, as decided by the doctor.
  • Women of childbearing potential must agree to use effective birth control during the study and have a negative pregnancy test before starting radiation.

Exclusion Criteria

  • Cannot have advanced cancer stages as defined by specific medical guidelines.
  • Cannot have had previous radiation to the head/neck that would overlap with current treatment areas.
  • Cannot have had major surgery to the head/neck that could affect lymph flow.
  • Cannot have uncontrolled illnesses that would interfere with radiation treatment, such as certain connective tissue disorders or psychiatric conditions that would limit study participation.

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