Study on Radiation Therapy Options for Treating Recurrent Head and Neck Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03164460

Provider View

This clinical trial is exploring two types of radiation therapy to see which is more effective in treating head and neck cancer that has returned. The study aims to determine if stereotactic body radiation therapy or intensity modulated radiation/proton therapy works better in reducing tumors and minimizing side effects.

Patient Parameters

Program Overview

This study is testing two different radiation therapies to treat head and neck cancer that has come back after previous treatment. One method, called stereotactic body radiation therapy (SBRT), uses precise equipment to target tumors with fewer doses, potentially causing less harm to healthy tissue. The other method, intensity modulated radiation/proton therapy (IMRT/IMPT), uses high-energy x-rays or protons to shrink tumors. The study will compare the effectiveness and side effects of these treatments to see which one works better for patients.

Description

The main goal of this study is to compare the side effects of two radiation treatments over two years. Researchers want to see if one treatment causes fewer severe side effects than the other. They will also look at how well each treatment controls the cancer and whether it helps patients live longer without the disease getting worse.

Patients will be randomly assigned to one of two groups. One group will receive stereotactic body radiation therapy (SBRT) every other day for a total of five treatments. The other group will receive intensity modulated radiation/proton therapy (IMRT/IMPT) once a day, Monday through Friday, for up to 30-35 treatments.

After finishing the treatment, patients will have follow-up visits at 2-3 months, then every 3 months for a year, and every 3-4 months for up to two years. During these visits, doctors will check on the patients' health and see how well the treatment worked.

The study will also look at patients' quality of life, treatment costs, and how the treatments affect different parts of the body. Researchers will gather information from patients about their symptoms and overall well-being to understand the impact of each treatment.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or new head and neck cancer confirmed by lab tests, and have previously received radiation treatment.
  • Not eligible for surgery or considered a poor candidate for surgery.
  • Have visible cancer on imaging tests like MRI or CT scans.
  • Have 1-3 sites of cancer recurrence, each less than 60 cc in size, with a total volume less than 100 cc.
  • Have an ECOG performance status of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have uncontrolled major health issues affecting the heart, lungs, kidneys, liver, digestive system, or blood.
    • Examples include severe heart failure, unstable chest pain, or irregular heartbeats not controlled by a pacemaker.
    • Have had a heart attack within the last 3 months.
  • Have cancer that has spread widely, although limited spread (oligometastatic disease) is acceptable.

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