Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy
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|ClinicalTrials.gov Identifier: NCT03042156|
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : June 1, 2020
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 radiotherapy 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 radiotherapy 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 radiotherapy 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 radiotherapy, 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 radiotherapy. This research is being done because there is limited information about the outcomes of combined immune therapy and radiotherapy 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 radiotherapy is given, but also outside the part of the body that receives radiotherapy (which is called "abscopal" effect).
|Condition or disease||Intervention/treatment|
|Palliative Advanced Cancer Immunotherapy Radiation Therapy||Radiation: Palliative Radiation Therapy|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy|
|Actual Study Start Date :||January 10, 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
- Number of patients showing rates of grade 3 or higher toxicity [ Time Frame: 4 months ]
Toxicity and safety data for combined therapy with immunotherapy and palliative RT (documentation that the rates of grade 3 or higher toxicity with combined therapy is < 30%) using patient reported outcomes (symptoms, toxicities, quality of life measures), clinical outcomes (physical examination, and CT imaging results) at baseline, 1 and 3 months post radiotherapy.
Only the highest toxicity/per patient will be used for analysis, regardless of the time point of when the information is collected
- In-field response on imaging and evidence of out of field (abscopal) response. [ Time Frame: 4 months ]Documentation of efficacy using CT imaging at 1 and 3 months post radiotherapy.
- The number of ESAS questionnaires completed with the aid of a caregiver [ Time Frame: 1 year ]Gather information on the efficacy collecting PRO's via in person or phone using questionnaires
- biomarkers analyses as an indicator of abscopal response [ Time Frame: 4 months ]Optional for consenting patients, done at 1 and 3 months post radiotherapy.
- The number of EQ5D questionnaires completed with the aid of a caregive [ Time Frame: 1 year ]Gather information on the efficacy collecting PRO's via in person or phone using questionnaires
- inflammatory and radiation sensitivity signatures from genotyping using archival tissue [ Time Frame: 1 year ]Optional - from consenting patients (n=10) who already have readily available archival tumour tissue
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042156
|Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Laura Dawson, MD 416-946-2127 Laura.Dawson@rmp.uhn.on.ca|
|Principal Investigator: Laura Dawson, MD|