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OligoprogressionNCT06918951

Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers

A study testing Stereotactic ablative radiotherapy (SABR) and Palliative radiotherapy in people with Oligoprogression and Oligometastatic Disease, run by British Columbia Cancer Agency at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

STOP-2 is a phase III multi-institutional double-blind randomized trial. 194 participants will be enrolled in this trial. Participants will be randomized in a 1:1 ratio between the Control Arm vs. the Experimental Arm. Participants, enrolling oncologists, and the statistician will be blinded to trial arm assignment. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Stereotactic ablative radiotherapy (SABR) and Palliative radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteCanada
Study dates
4 Dec 2025to 1 Jun 2033
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 19 or older
  • Able to provide informed consent
  • Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging
  • Biopsy of metastasis at some time prior to enrollment is preferred, but not required
  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
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  • Progression meeting RECIST criteria in up to 5 individual lesions. Progression may be defined as:
  • Progression of an individual metastasis according to RECIST 1.1 criteria (≥ 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during systemic therapy, and associated with a 5 mm minimum increase in size) OR
  • Unambiguous development of a new metastatic lesion at least 5 mm in size OR
  • Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart with a minimum 5 mm increase in size from baseline.
  • A progressing primary tumor is eligible as per the criteria above
  • If the participant is on systemic therapy at the time of oligoprogression:
  • The most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR), complete response (CR) or stable disease (SD) prior to the development of oligoprogressive lesions
  • If the participant is not on systemic therapy at the time of oligoprogression:
  • (i.e., "oligorecurrence"(1), however, included as "oligoprogression" for the purpose of this study protocol):
  • There must be PR, CR or SD persisting for at least 3 months prior to the development of oligoprogressive lesions
  • Participants who are not on systemic therapy at the time of oligoprogression must have other site(s) of disease (metastases or primary tumor) that are stable or resolved and have not received definitive treatment (inclusive of surgery, radical doses of radiotherapy including SABR, or ablation) and are not going to receive SABR.
  • All sites of oligoprogression can be safely treated
  • Restaging completed within 12 weeks prior to randomization (see section 5.1)
  • Negative urine pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of radiotherapy start date.

Who cannot join

  • Serious medical comorbidities precluding radiotherapy. These include ataxia-telangiectasia or scleroderma, Crohn's disease in participants where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy.
  • For participants with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease.
  • Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, provided that the composite plan meets dose constraints herein. For participants treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. A tissue recovery factor may be used in these calculations and if so, must be clearly documented, along with elapsed time from previous radiotherapy, and approved by the local principal investigator.
  • Current malignant pleural effusion, malignant ascites, or leptomeningeal disease
  • Inability to treat all sites of oligoprogressive disease
  • Liver metastases requiring placement of fiducial markers for SABR, as this would compromise successful blinding. Liver metastases are eligible if: 1) they are treated at an institution that offers liver SABR without fiducial markers or 2) pre-existing markers such as surgical clips or calcifications would serve as fiducial markers
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  • Brain metastasis > 3.5 cm in size or a total volume of brain metastases greater than 30 cc.
  • Clinical or radiologic evidence of spinal cord compression. Participants can be eligible if surgical resection has been performed.
  • Participants with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of >12.
  • Dominant brain metastasis requiring surgical decompression
  • For participants with liver metastases; moderate/severe liver dysfunction (Child Pugh B or C)
  • Liver metastases located in the "Biliary no fly zone" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm
  • Surgical resection of all oligoprogression metastases (i.e. no lesion available to be treated with SABR)
  • Pregnant or lactating individuals

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah Baker, MD, PhD, FRCPC contact

604-930-4032

sarah.baker1@bccancer.bc.ca

Canada1 site, 1 recruiting
  • BC Cancer - Surrey

    Surrey, British Columbia, V3V 1Z2

    Sarah Baker, MD, PhD, FRCPC, 604-930-4032, sarah.baker1@bccancer.bc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers: A Double-Blind Randomized Phase III Trial

STOP-2 is a phase III multi-institutional double-blind randomized trial. 194 participants will be enrolled in this trial. Participants will be randomized in a 1:1 ratio between the Control Arm vs. the Experimental Arm.

Participants, enrolling oncologists, and the statistician will be blinded to trial arm assignment.

Read more

In the control arm, radiotherapy will consist of 8 Gy in 1 fraction to all sites of oligoprogression, and the experimental arm will consist of SABR treatment to all sites of oligoprogression.

Primary Objectives

  • To assess the impact of SABR, compared to palliative conventional radiotherapy, on Progression-free survival on next line systemic therapy (PFS-NEST), oncologic outcomes, and Quality of Life (QOL) in participants with 1-5 oligoprogressing lesions.
  • To assess the feasibility of the clinical trial in terms of accrual and success of double-blinding.

Secondary Objectives

  • To evaluate and compare the impact of SABR and palliative radiation therapy on the overall survival (OS), progression free survival (PFS), polymetastatic progression-free survival (PPFS);
  • To assess and compare the proportion of participants receiving additional radiation therapy and other metastasis-directed interventions during follow-up between both arms;
  • To compare the impact of SABR and palliative radiation therapy on the time to initiation of the next line of systemic therapy;
  • To identify and compare the anatomic sites of disease progression between the experimental (SABR) and control (palliative radiation) arms;
  • To compare the treatment related toxicity among participants in each arm;
  • To evaluate and compare the quality of life among participants in each arm;
  • To assess the cost-effectiveness of the experimental arm compared to the control arm.
Being tested
Stereotactic ablative radiotherapy (SABR), Palliative radiotherapy
Keywords
SABR, Radiotherapy, Quality of life, Metastatic Cancer
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic ablative radiotherapy (SABR)Radiation

    SABR is a safe and effective modality for metastasis-directed therapy, delivering a high dose of radiotherapy to a small target using conformal techniques. Emerging evidence suggests that SABR for oligoprogressive cancer may extend the duration of systemic therapy, and result in improvements in Progression Free Survival (PFS) and Overall Survival (OS) compared to historic controls.

  • Palliative radiotherapyRadiation

    Radiotherapy will consist of 8 Gy in 1 fraction to all sites of oligoprogression.

    Participants will continue their current systemic therapy (if already on systemic therapy at the time of oligoprogression event) or continue off systemic therapy (if the participant was not on systemic therapy at the time of the oligorecurrence event).

Study groups in NCT06918951
Study groupRoleWhat they receive
Control Arm (Palliative Radiotherapy)Active comparatorNot described
Receives: Radiation: Palliative radiotherapy
Experimental Arm (SABR)ExperimentalNot described
Receives: Radiation: Stereotactic ablative radiotherapy (SABR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival on Next Line Systemic Therapy (PFS-NEST)

    Time from randomization to progression (RECIST criteria) beyond next line of systemic therapy or death from any cause or date of last follow-up, whichever occurs first. Next line systemic therapy is the first new systemic therapy initiated after documented disease progression

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  2. Evaluation of feasibility of the clinical trial in terms of successful accrual

    Accrual will be measured by the number of participants enrolled in the trial within the specified time frame.

    Measured: 12 and 24 months

  3. Evaluation of feasibility of the clinical trial in terms of success of double-blinding

    The success of double-blinding will be measured by providing both the participant and oncologist with a blinding questionnaire asking them to select the suspected trial arm assignment (options include palliative arm, SABR arm, or unknown).

    Measured: 6 weeks

Secondary outcomes (10)
  1. Evaluation of OS, PFS, and PPFS

    To evaluate and compare the impact of SABR and palliative radiation therapy on the overall survival (OS), progression free survival (PFS), polymetastatic progression-free survival (PPFS);

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  2. Time to next line systemic therapy

    To assess and compare the proportion of participants receiving additional radiation therapy and other metastasis-directed interventions during follow-up between both arms;

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  3. Comparing the anatomic sites of disease progression

    A list of anatomical sites at which there are new or progressing lesions will be collected

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  4. Evaluation of the treatment related toxicities

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g., liver, lung, bone)

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  5. Comparing the quality of life among participants in each arm using Functional Assessment of Cancer Therapy: General (FACT-G)

    Quality of life will be assessed with the FACT-G questionnaire. The FACT-G score ranges from 0 to 108, with higher scores indicating a better quality of life.

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  6. Comparing the quality of life among participants in each arm using EuroQol 5-Dimension 5-Level (EQ-5D-5L)

    Quality of life will be assessed with the EQ-5D-5L questionnaire. The EQ-5D-5L index score ranges from -0.224 to 1, with higher scores indicating a better quality of life.

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  7. Comparing cost-effectiveness of the arms using the resource utilization forms

    Costs associated with each treatment arm will be measured using resource utilization forms.

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  8. Comparing cost-effectiveness of the arms using the EQ-5D-5L

    Costs associated with each treatment arm will be measured using EQ-5D-5L

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  9. Evaluation of Tumor Response Rate (TRR) using RECIST Criteria

    Tumor response rate will be assessed using RECIST criteria.

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

  10. Evaluation of Quality of Life (QOL) using European Organization For Research And Treatment Of Cancer (EORTC QLQ-C30) Questionnaire

    Health-related quality of life will be measured using the EORTC QLQ-C30 questionnaire, covering physical functioning, emotional functioning, and symptom scales.

    This questionnaire consists of 30 items, and the score range is 0-100. On this scale, a higher score indicates a higher (better) level of functioning or a higher (worse) level of symptoms, depending on the type of scale.

    Measured: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start4 Dec 2025
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2033 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
This study is a phase III, multicenter, double-blind, randomized trial. Participants will be randomized in a 1:1 ratio between conventional palliative radiotherapy (Control Arm; Arm 1) vs. SABR (Experimental Arm; Arm 2) to all sites of oligoprogressing disease.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06918951
Sponsor's protocol ID
STOP-2
Status last verified
Dec 2025
First submitted
10 Mar 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic ablative radiotherapy (SABR) and Palliative radiotherapy in people with Oligoprogression and Oligometastatic Disease, run by British Columbia Cancer Agency 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 20 inclusion and 14 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 15 Dec 2025. 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?

Contact Sarah Baker, MD, PhD, FRCPC (604-930-4032, sarah.baker1@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival on Next Line Systemic Therapy (PFS-NEST) (time frame: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months). 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?
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 15 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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