PalliativeNCT03042156
Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy
An observational study of Palliative and Advanced Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative, Advanced Cancer, Immunotherapy
- What is being tested?
- Palliative Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2017to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Adults aged 18 years or older
- Histologically or cytologically confirmed solid tumor malignancy
- Advanced disease (locally advanced and/or metastatic)
- Life expectancy > 3 months
- Patients planned to receive palliative radiotherapy (including whole liver radiotherapy)
- Patients who are already on or about to commence a checkpoint inhibitor
Show all 14Show fewer
- Measurable disease according to irRECIST on CT or MRI
- ECOG performance status 0-2
- Able to provide informed consent
- Able to complete telephone/email communication
- Additional criteria for subset of patients for abscopal analysis (to be done post hoc):
- Measurable disease outside irradiated volume
- 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
- Availability of prior biopsy specimen (preferably fresh frozen tissue) for research and genotyping
Who cannot join
- Medical conditions which may be contraindications to radiotherapy
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Palliative, Advanced Cancer, Immunotherapy, Radiation Therapy
- Being tested
- Palliative Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Radiation TherapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients showing rates of grade 3 or higher toxicity
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
Measured: 4 months
Secondary outcomes (4)
In-field response on imaging and evidence of out of field (abscopal) response.
Documentation of efficacy using CT imaging at 1 and 3 months post radiotherapy.
Measured: 4 months
The number of ESAS questionnaires completed with the aid of a caregiver
Gather information on the efficacy collecting PRO's via in person or phone using questionnaires
Measured: 1 year
biomarkers analyses as an indicator of abscopal response
Optional for consenting patients, done at 1 and 3 months post radiotherapy.
Measured: 4 months
The number of EQ5D questionnaires completed with the aid of a caregive
Gather information on the efficacy collecting PRO's via in person or phone using questionnaires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start10 Jan 2017
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PalliativeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042156
- Sponsor's protocol ID
- 16-6189
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2016
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy And Palliative Radiotherapy Combined In Patients With Advanced Malignancy
- ClinicalTrials.gov ID
- NCT03042156
- Acronym / sponsor ID
- 16-6189
- Conditions
- Palliative, Advanced Cancer, Immunotherapy, Radiation Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (14 listed)
- Adults aged 18 years or older
- Histologically or cytologically confirmed solid tumor malignancy
- Advanced disease (locally advanced and/or metastatic)
- Life expectancy > 3 months
- Patients planned to receive palliative radiotherapy (including whole liver radiotherapy)
Key exclusion criteria (2 listed)
- Medical conditions which may be contraindications to radiotherapy
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Radiation Therapy | Radiation | – |
Primary outcome
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
4 secondary outcomes
In-field response on imaging and evidence of out of field (abscopal) response.
Time frame: 4 months
The number of ESAS questionnaires completed with the aid of a caregiver
Time frame: 1 year
biomarkers analyses as an indicator of abscopal response
Time frame: 4 months
The number of EQ5D questionnaires completed with the aid of a caregive
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative and Advanced Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients showing rates of grade 3 or higher toxicity (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.