MalignancyRADIANTNCT04122469
The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease
A study testing Stereotactic Body Radiotherapy in people with Malignancy and Breast Cancer Metastatic, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progression has become a recognized entity for metastatic cancer and it is thought that a subset of cancer cells may develop heterogeneity and resistant clones while receiving systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy, Breast Cancer Metastatic, Genito-urinary
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2019to Sep 2027
- Phase
- Interventional
- 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
- Adult patients ≥18 years accrued at the Princess Margaret Cancer Centre
- 5 or less sites of intra or extra-cranial oligo-progressive, de novo oligo-metastatic, induced oligo-metastatic and repeat oligo-metastatic breast disease amenable to ablative treatment (including but not limited to radiotherapy, surgery, radio-frequency ablation);
- o at least one lesion should be planned for SBRT
- OR 5 or less sites of intra or extra-cranial oligo-progressive prostate, bladder and renal cell carcinomas
- Tumor mass amenable to SABR (≤6cm in size)
- Confirmation of diagnosis:
Show all 19Show fewer
- Known/documented prior histological (for all excluding HCC) or radiological diagnosis (for HCC) of:
- Pathologically confirmed breast cancer OR,
- Pathologically confirmed GU cancer (such as prostate cancer, bladder cancer, or radiologically or pathologically confirmed RCC).
- For prostate patients only: Known metastatic disease treated with ADT (patients who received other ST as first line treatment of mCSPC would be eligible; eg Docetaxel, Abiraterone…)
- For prostate patients only: Known metastatic CRPC progressing on ST (Docetaxel, Abiraterone, Enzalutamide…)
- For oligo-progressive disease: receiving any form of ST for at least 3 months with (ST breaks are permitted):
- Radiographic evidence of ≤3 intra or extra-cranial lesions progressing (including nodal or distant). At least one lesion is suitable for SBRT. Each progressing lesion should fulfill at least 1 of the 3 following criteria for oligo-progression:
- Progression of a metastasis according to RECIST 1.1 criteria7
- Unambiguous development of a new lesion from the time of scan taken prior to starting ST
- Progressive enlargement of a known metastasis on 2 consecutive imaging (CT or MRI) 2-3 months apart, while on ST, with a minimum 5 mm increase in size from baseline.
- Remainder of metastatic disease stable or regressing, as per RECIST v1.1, evidenced by >2 consecutive images within the past 4-6 months.
- Able to provide written consent
- ECOG performance status 0-3
Who cannot join
- ≥6 progressive metastases
- Evidence of spinal cord compression or acute event requiring urgent/emergency radiotherapy
- Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
- Previous radical RT in the area of OP
- Inability to safely treat all sites of progressing metastases
- Patient cannot tolerate physical set-up required for SBRT
Show all 10Show fewer
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
- Active bowel obstruction, if treating abdominal/pelvic site
- Neuroendocrine, lymphoma, myeloma or germ cell malignancies
- Familial syndromes: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuberous Sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progression has become a recognized entity for metastatic cancer and it is thought that a subset of cancer cells may develop heterogeneity and resistant clones while receiving systemic therapy. This results in overall tumor response but progression in metastatic sites. Current standard is to change systemic therapies. With advancing technologies, stereotactic body radiation therapy is being used to deliver high doses of focused radiation to the disease site, while minimizing risk of injury to the surrounding organs. SBRT is increasingly being used in patients presenting oligo-metastatic disease, and is recognized as having a potential for cure. This study will investigate the use of SBRT for breast and genito-urinary cancer patients with oligo-progression. Patients will be seen before and at the end of treatment and will be followed at 4 month intervals for up to 2 years.
During the visits participants will complete quality of life questionnaires and will have standard of care imaging.
Patients will also have the option to provide blood at baseline, during treatment, and at various follow up time points for analysis of ctDNA
- Conditions
- Malignancy, Breast Cancer Metastatic, Genito-urinary
- Being tested
- Stereotactic Body Radiotherapy
- Keywords
- SBRT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyRadiation
The purpose of this study is to evaluate the safety, and efficacy of SBRT in this patient population
| Study group | Role | What they receive |
|---|---|---|
| Oligo-Progression; GU | Experimental | Receiving SBRT. Receives: Radiation: Stereotactic Body Radiotherapy |
| Oligo-metastatic Breast Cancer | Experimental | Receiving SBRT. Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of SBRT in OP malignancies
To determine the safety of SBRT in OP malignancies over a 24-month follow-up period using CTCAE v5.0.
Measured: 24 month period
Efficacy of SBRT in OP malignancies
To determine the efficacy of SBRT in OP malignancies over a 24-month follow-up period by evaluating progression-free survival. Radiographic local control of irradiated areas and local disease will also be used to determine efficacy by using Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: 24 month period
Feasibility of SBRT in OP malignancies
To determine the feasibility of SBRT in OP malignancies over a 24-month follow-up period using the a quality of life questionnaire (the EORTC QLQ-C30 questionnaire).
Measured: 24 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start11 Sep 2019
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalignancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
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
- NCT04122469
- Sponsor's protocol ID
- 18-6047
- Acronym
- RADIANT
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2019
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Glicksman RM, Raman S, Ye XY, Bedard PL, Bratman S, Chen E, Chung P, Dawson LA, Hope A, Hosni A, Javor J, Lindsay P, O'Brien C, Wong R, Barry A, Helou J. The Role of Stereotactic Body Radiotherapy in Oligoprogressive Malignant Disease (RADIANT): Oncologic Outcomes From a Phase 2 Nonrandomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2025 Feb 1;121(2):292-306. doi: 10.1016/j.ijrobp.2024.09.002. Epub 2024 Sep 11.
PubMed 39270828
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease
- ClinicalTrials.gov ID
- NCT04122469
- Acronym / sponsor ID
- RADIANT / 18-6047
- Conditions
- Malignancy, Breast Cancer Metastatic, Genito-urinary
- Keywords
- SBRT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Oct 2019 (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.
Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progression has become a recognized entity for metastatic cancer and it is thought that a subset of cancer cells may develop heterogeneity and resistant clones while receiving systemic therapy. This results in overall tumor response but progression in metastatic sites. Current standard is to change systemic therapies. With advancing technologies, stereotactic body radiation therapy is being used to deliver high doses of focused radiation to the disease site, while minimizing risk of injury to the surrounding organs. SBRT is increasingly being used in patients presenting oligo-metastatic disease, and is recognized as having a potential for cure. This study will investigate the use of SBRT for breast and genito-urinary cancer patients with oligo-progression. Patients will be seen before and at the end of treatment and will be followed at 4 month intervals for up to 2 years.
During the visits participants will complete quality of life questionnaires and will have standard of care imaging.
Patients will also have the option to provide blood at baseline, during treatment, and at various follow up time points for analysis of ctDNA
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligo-Progression; GU | Experimental | Radiation: Stereotactic Body RadiotherapyReceiving SBRT. |
| Oligo-metastatic Breast Cancer | Experimental | Radiation: Stereotactic Body RadiotherapyReceiving SBRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adult patients ≥18 years accrued at the Princess Margaret Cancer Centre
- 5 or less sites of intra or extra-cranial oligo-progressive, de novo oligo-metastatic, induced oligo-metastatic and repeat oligo-metastatic breast disease amenable to ablative treatment (including but not limited to radiotherapy, surgery, radio-frequency ablation);
- o at least one lesion should be planned for SBRT
- OR 5 or less sites of intra or extra-cranial oligo-progressive prostate, bladder and renal cell carcinomas
- Tumor mass amenable to SABR (≤6cm in size)
Key exclusion criteria (10 listed)
- ≥6 progressive metastases
- Evidence of spinal cord compression or acute event requiring urgent/emergency radiotherapy
- Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
- Previous radical RT in the area of OP
- Inability to safely treat all sites of progressing metastases
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 |
|---|---|---|
| Stereotactic Body RadiotherapyThe purpose of this study is to evaluate the safety, and efficacy of SBRT in this patient population | Radiation | Oligo-Progression; GU, Oligo-metastatic Breast Cancer |
Primary outcome
Safety of SBRT in OP malignancies
Time frame: 24 month period
To determine the safety of SBRT in OP malignancies over a 24-month follow-up period using CTCAE v5.0.
Efficacy of SBRT in OP malignancies
Time frame: 24 month period
To determine the efficacy of SBRT in OP malignancies over a 24-month follow-up period by evaluating progression-free survival. Radiographic local control of irradiated areas and local disease will also be used to determine efficacy by using Response Evaluation Criteria in Solid Tumors (RECIST).
Feasibility of SBRT in OP malignancies
Time frame: 24 month period
To determine the feasibility of SBRT in OP malignancies over a 24-month follow-up period using the a quality of life questionnaire (the EORTC QLQ-C30 questionnaire).
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 4 Jun 2026.
- Derived from this study: PubMed 39270828Glicksman RM, Raman S, Ye XY, Bedard PL, Bratman S, Chen E, Chung P, Dawson LA, Hope A, Hosni A, Javor J, Lindsay P, O'Brien C, Wong R, Barry A, Helou J. The Role of Stereotactic Body Radiotherapy in Oligoprogressive Malignant Disease (RADIANT): Oncologic Outcomes From a Phase 2 Nonrandomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2025 Feb 1;121(2):292-306. doi: 10.1016/j.ijrobp.2024.09.002. Epub 2024 Sep 11.
Related trials for Malignancy
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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?
A study testing Stereotactic Body Radiotherapy in people with Malignancy and Breast Cancer Metastatic, 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 19 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 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?
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?
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?
Safety of SBRT in OP malignancies (time frame: 24 month period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122469, which also lists 1 linked publication.
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 Jun 2026.