Immunotherapy And Palliative Radiation Therapy Combined In Patients With Advanced Malignancy

Official Title

Immunotherapy And Palliative Radiation Therapy Combined In Patients With Advanced Malignancy

Summary:

Immunotherapy includes a class of medication called checkpoint inhibitors, which are a relatively new medication therapy for many types of cancer which are metastatic, meaning it has spread to other parts of the body.Immune therapy medication may be given safely with radiation treatment, and in rare cases it may even make radiation therapy more effective. When radiation therapy is given in the "palliative" setting it is given to treat pain/discomfort and not necessarily shrink or get rid of the tumour. Palliative radiation therapy may be given for many reasons, but common examples include painful bone or liver tumours, brain metastases, or symptoms from a chest tumour such as feeling breathless, cough, or bleeding. Palliative radiation therapy is usually given in smaller amounts and less frequently than other types of radiation therapy. Because checkpoint inhibitors are relatively new there is not a huge amount of evidence looking at how patients respond when the treatments are combined, or in which patients immune therapy may make radiation therapy even more effective. This study is looking at the way patients who are on or about to start immune therapy and who have been recommended for palliative radiation therapy, respond to the combination of these two treatments. The purpose of this study is to describe the treatment outcomes in patients with cancer that has spread who are managed with a combination of immune therapy medication and radiation therapy. This research is being done because there is limited information about the outcomes of combined immune therapy and radiation therapy treatment from a patient's perspective, but also in terms of which patients may have a better response to combined treatment. In particular, the study aims to describe how combined treatment affects cancer not only in the area where radiation therapy is given, but also outside the part of the body that receives radiation therapy (which is called "abscopal" effect).

Trial Description

Primary Outcome:

  • Number of patients showing rates of grade 3 or higher toxicity
Secondary Outcome:
  • In-field response on imaging and evidence of out of field (abscopal) response.
  • The number of ESAS questionnaires completed with the aid of a caregiver
  • biomarkers analyses as an indicator of abscopal response
  • The number of EQ5D questionnaires completed with the aid of a caregive

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society