Solid Tumors With Oligometastatic SpreadPhase 25fr SBRTNCT01761929
5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases
A Phase 2 study testing Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance in people with Solid Tumors With Oligometastatic Spread, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors With Oligometastatic Spread
- What is being tested?
- Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2013to 8 Feb 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded.
- Histological confirmation of neoplastic disease either from original primary or metastatic sites is required.
- Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory.
- Oligometastatic disease, maximum of 5 lesions.
- At least one lesion is suitable for stereotactic body radiotherapy
- All known sites of disease have plans for local ablative management (see section management plan for definitions) within 3 months
- ECOG ≤ 2
- At least 18 yrs old
Who cannot join
- Previous radiotherapy to the intended treatment site
- Patient cannot tolerate physical set up required for SBRT
- Active bowel obstruction, if treating abdominal/pelvic site
- Chemotherapy within 2 weeks of intended radiation therapy
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases
This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.
The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.
Read the detailed description
Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.
- Conditions
- Solid Tumors With Oligometastatic Spread
- Being tested
- Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance
- Keywords
- oligometastatic, oligometastases, stereotactic body radiotherapy, radiation therapy, Oligometastasis, Stereotactic ablative body, radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue toleranceRadiation
All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice. Receives: Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with lack of progressive disease for the index site at 1 year
CT will be used for evaluation of the status of the local disease at the index site.
Measured: 10 years
Secondary outcomes (7)
Number of index lesion(s) with lack of progressive disease at 1 year.
The Modified Response Evaluation Criteria for solid Tumors (RECIST) will be used. By measuring the longest diameter (LD) of the lesions, response of individual lesions and overall response will be documented.
Measured: 10 years
Acute toxicity within 90 days of first fraction of radiotherapy
Acute toxicity will be graded according to the Common Toxicity Criteria, v4.0
Measured: 10 years
Time to local progression for the index site(s)
Measured: 10 years
Time to distant disease progression (beyond known sites of oligometastases at time of study entry)
Measured: 10 years
Late toxicity occuring beyond 90 days related to SBRT.
Late toxicity will be graded according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score.
Measured: 10 year
Describe symptom profile
Measured: 10 Years
Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study start7 Mar 2013
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors With Oligometastatic SpreadStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Rebecca K.S. Wong, MB ChB, Principal investigator, University Health Network - Princess Margaret Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761929
- Sponsor's protocol ID
- 11-0886
- Acronym
- 5fr SBRT
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2012
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases
- ClinicalTrials.gov ID
- NCT01761929
- Acronym / sponsor ID
- 5fr SBRT / 11-0886
- Conditions
- Solid Tumors With Oligometastatic Spread
- Keywords
- oligometastatic, oligometastases, stereotactic body radiotherapy, radiation therapy, Oligometastasis, Stereotactic ablative body, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 7 Mar 2013 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 7 Jan 2013 (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.
This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.
The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.
Detailed description
Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue toleranceAll patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded.
- Histological confirmation of neoplastic disease either from original primary or metastatic sites is required.
- Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory.
- Oligometastatic disease, maximum of 5 lesions.
- At least one lesion is suitable for stereotactic body radiotherapy
Key exclusion criteria (6 listed)
- Previous radiotherapy to the intended treatment site
- Patient cannot tolerate physical set up required for SBRT
- Active bowel obstruction, if treating abdominal/pelvic site
- Chemotherapy within 2 weeks of intended radiation therapy
- Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
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 |
|---|---|---|
| Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue toleranceAll patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice. | Radiation | Stereotactic Body Radiation Therapy |
Primary outcome
Proportion of patients with lack of progressive disease for the index site at 1 year
Time frame: 10 years
CT will be used for evaluation of the status of the local disease at the index site.
7 secondary outcomes
Number of index lesion(s) with lack of progressive disease at 1 year.
Time frame: 10 years
Acute toxicity within 90 days of first fraction of radiotherapy
Time frame: 10 years
Time to local progression for the index site(s)
Time frame: 10 years
Time to distant disease progression (beyond known sites of oligometastases at time of study entry)
Time frame: 10 years
Late toxicity occuring beyond 90 days related to SBRT.
Time frame: 10 year
Describe symptom profile
Time frame: 10 Years
Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities
Time frame: 10 years
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 6 Mar 2026.
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.
Rebecca K.S. Wong, MB ChB principal investigator
University Health Network - Princess Margaret Cancer Center
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 Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance in people with Solid Tumors With Oligometastatic Spread, 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 8 inclusion and 6 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 6 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.
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?
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?
Proportion of patients with lack of progressive disease for the index site at 1 year (time frame: 10 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 6 Mar 2026.