Metastatic CancerPhase 2SUPPRESSNCT04989725
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
A Phase 2 study testing Standard arm and Experimental arm in people with Metastatic Cancer and Oligoprogressive, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
A registry-based randomized phase II trial. A total of 46 patients with metastatic cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Oligoprogressive
- What is being tested?
- Standard arm and Experimental arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years
- Metastatic cancer (any histology), with pathological or radiological proof of metastasis
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
- Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
- All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
- Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
Who cannot join
- Pregnancy or breastfeeding
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
- Presence of spinal cord compression
- Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Silvine Benth, 514-890-8254, silvine.benth.chum@ssss.gouv.qc.ca
Houda Bahig, MD, PhD
About this study
Official title: Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial
A registry-based randomized phase II trial. A total of 46 patients with metastatic cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
- Conditions
- Metastatic Cancer, Oligoprogressive
- Being tested
- Standard arm, Experimental arm
- Keywords
- metastatic cancer, oligoprogression
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard armOther
Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
Experimental armRadiation
SABR to all oligoprogressive lesions + continuation of current systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Switch to subsequent systemic therapy line, best supportive care or continue current systemic line Receives: Other: Standard arm |
| Experimental SABR arm | Experimental | Definitive SABR to oligoprogressive lesions + continue current systemic therapy Receives: Radiation: Experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
PFS defined from randomization to disease progression at any site or death
Measured: 5 years
Secondary outcomes (5)
Overall survival
OS defined as time from randomization to time of death from any cause.
Measured: 5 years
Quality of life Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D
Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D
Measured: 5 years
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured using the Common Terminology Criteria for Adverse Events
Measured: 5 years
Local control
Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm
Measured: 5 years
Time to next systemic therapy
Defined as time from randomization to time of subsequent therapy line
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized screening phase II trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989725
- Sponsor's protocol ID
- Suppress
- Acronym
- SUPPRESS
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial
- ClinicalTrials.gov ID
- NCT04989725
- Acronym / sponsor ID
- SUPPRESS / Suppress
- Conditions
- Metastatic Cancer, Oligoprogressive
- Keywords
- metastatic cancer, oligoprogression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 4 Aug 2021 (actual)
- 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.
A registry-based randomized phase II trial. A total of 46 patients with metastatic cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized screening phase II trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard armSwitch to subsequent systemic therapy line, best supportive care or continue current systemic line |
| Experimental SABR arm | Experimental | Radiation: Experimental armDefinitive SABR to oligoprogressive lesions + continue current systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Metastatic cancer (any histology), with pathological or radiological proof of metastasis
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
- Presence of spinal cord compression
- Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel
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 |
|---|---|---|
| Standard armPatients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy. | Other | Standard of care |
| Experimental armSABR to all oligoprogressive lesions + continuation of current systemic therapy | Radiation | Experimental SABR arm |
Primary outcome
Progression free survival
Time frame: 5 years
PFS defined from randomization to disease progression at any site or death
5 secondary outcomes
Overall survival
Time frame: 5 years
Quality of life Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D
Time frame: 5 years
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Time frame: 5 years
Local control
Time frame: 5 years
Time to next systemic therapy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard arm and Experimental arm in people with Metastatic Cancer and Oligoprogressive, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvine Benth (514-890-8254, silvine.benth.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 5 years). 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 22 Jul 2026.