Study on Radiation Therapy for Patients with Metastatic Cancer That Has Worsened After Immunotherapy

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02710253

Provider View

This clinical trial is exploring the use of radiation therapy to treat patients whose cancer has spread or grown after receiving immunotherapy. The study aims to find the best dose and understand the side effects of radiation therapy in controlling cancer that has progressed.

Patient Parameters

Program Overview

This study is investigating how well radiation therapy works in treating patients with cancer that has spread to other parts of the body or has grown after being treated with immunotherapy. The goal is to see if radiation can help control the cancer after it has worsened following immunotherapy treatment.

Description

The main goals of this study are to identify which immunotherapy treatments work well with radiation to control cancer and to find out if there are any significant side effects when using radiation after immunotherapy.

The study will also look at how often the cancer is controlled after radiation, how long patients live after receiving radiation, and how long they remain free from cancer progression.

Patients will receive either 4, 5, or 10 sessions of a type of radiation called stereotactic body radiation therapy (SBRT), or 5-15 sessions of external beam radiation therapy (EBRT) to areas where the cancer has spread. The treatment will be given daily over a period of 4 days to 3 weeks, as decided by the doctor. If the cancer is stable after the second imaging test, patients may receive additional radiation sessions.

After finishing the treatment, patients will have follow-up visits 30 days later, and then every 12 weeks for up to a year to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of cancer.
  • Cancer has worsened after previous immunotherapy treatment or requires radiation as decided by the doctor.
  • Have at least one area of cancer that can be treated with radiation.
  • Be willing to provide written consent to participate in the study.
  • Be 18 years or older.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Women of childbearing potential must have a negative pregnancy test before starting radiation.
  • Previous radiation to other areas is allowed if it does not overlap with the new treatment area or if the overlap is minimal.
  • Non-English speakers can participate.

Exclusion Criteria

  • Have active autoimmune diseases like scleroderma or lupus that make radiation unsafe.
  • Have had radiation in the past 3 months that overlaps with the new treatment area.
  • Have not recovered from side effects of previous treatments, unless they are mild or managed with routine care.
  • Have an active infection requiring hospital treatment.
  • Have psychiatric or substance abuse issues that prevent following the study requirements.
  • Are pregnant or planning to become pregnant during the study period.

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