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Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03042156
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : June 1, 2020
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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 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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. biomarkers analyses as an indicator of abscopal response [ Time Frame: 4 months ]
    Optional for consenting patients, done at 1 and 3 months post radiotherapy.

  4. 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

Other Outcome Measures:
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced malignancy referred for palliative radiotherapy for symptom control who are either (a) already on a checkpoint inhibitor or (b) about to start immunotherapy (including PD1 inhibitors, CTLA4 inhibitors or other novel checkpoint inhibitor agents)

Inclusion Criteria:

  1. Adults aged 18 years or older
  2. Histologically or cytologically confirmed solid tumor malignancy
  3. Advanced disease (locally advanced and/or metastatic)
  4. Life expectancy > 3 months
  5. Patients planned to receive palliative radiotherapy (including whole liver radiotherapy)
  6. Patients who are already on or about to commence a checkpoint inhibitor
  7. Measurable disease according to irRECIST on CT or MRI
  8. ECOG performance status 0-2
  9. Able to provide informed consent
  10. Able to complete telephone/email communication
  11. Additional criteria for subset of patients for abscopal analysis (to be done post hoc):

    1. Measurable disease outside irradiated volume
    2. Must be on same checkpoint inhibitor/immunotherapy (or same class of checkpoint inhibitor) for 3 months prior to radiotherapy and have stable disease or oligoprogression in past 3 months
    3. Availability of prior biopsy specimen (preferably fresh frozen tissue) for research and genotyping

Exclusion Criteria:

  1. Medical conditions which may be contraindications to radiotherapy
  2. Any medical or non-medical issue that would affect the patient's ability to provide informed consent for study participation, or would interfere with the patient's treatment on study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03042156

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Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Laura Dawson, MD    416-946-2127   
Principal Investigator: Laura Dawson, MD         
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT03042156    
Other Study ID Numbers: 16-6189
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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