Comparing Palliative radiotherapy with Stereotactic ablative radiotherapy for oligoprogression
Official title: Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers
Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers: A Double-Blind Randomized Phase III Trial
- 2 groups
- One site, in Surrey
- Recruiting
Interventions
- Radiation therapy
Stereotactic ablative radiotherapy (SABR)
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.
- Radiation therapy
Palliative radiotherapy
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).
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
BC Cancer - Surrey
Surrey, British Columbia
Eligibility Criteria
See who this study is looking for34 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart with a minimum 5 mm increase in size from baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- +Histologically confirmed solid malignancy (excluding lymphoma or myeloma) with metastatic disease detected on imaging
- +Age 19 or older
- +Able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Biopsy of metastasis at some time prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → is preferred, but not required
- +Life expectancy ≥ 6 months
- +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
- +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 protocolProtocolThe detailed plan a study must follow.Read more →):
- +There must be PR, CR or SD persisting for at least 3 months prior to the development of oligoprogressive lesions
- +All sites of oligoprogression can be safely treated
- +Restaging completed within 12 weeks prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (see section 5.1)
- +ECOG performance status 0-2
- +Negative urine pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of radiotherapy start date.
- +Participants who are not on systemic therapy at the time of oligoprogression must have other siteTrial siteA hospital or clinic where a study is actually run.Read more →(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.
Exclusion
- −Current malignant pleural effusion, malignant ascites, or leptomeningeal disease
- −Brain metastasis \> 3.5 cm in size or a total volume of brain metastases greater than 30 cc.
- −Dominant brain metastasis requiring surgical decompression
- −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.
- −a. For participants with oligoprogressive lesions in the lung or thorax, this includes interstitial lung 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
- −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.
- −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
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Palliative radiotherapy.
Registry label: A: Control Arm (Palliative Radiotherapy)
Group B receives Stereotactic ablative radiotherapy (SABR).
Registry label: B: Experimental Arm (SABR)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 19 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 194 people.
The study is currently expected to finish around June 2033.
The main measurement is taken over: 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival on Next Line Systemic Therapy (PFS-NEST) — measured over 3 months, 6 months, 12 months, 15 months, 18 months, 21 months, 24 months, 36 months, 42 months, 48 months, 54 months, 60 months.
Evaluation of feasibility of the clinical trialInterventional studyA study where participants are given something to see what happens.Read more → in terms of successful accrualEnrolmentThe number of participants a study plans to include, or has included.Read more → — measured over 12 and 24 months.
Evaluation of feasibility of the clinical trial in terms of success of double-blinding — measured over 6 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06918951 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About 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).
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 19 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 19 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 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 as a whole is currently expected to finish around 2033-06-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 194 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Surrey, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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. 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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.