Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorBritish Columbia Cancer Agency
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
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
Trial design
Design model
Parallel
Treatments tested in this trial
Stereotactic ablative radiotherapy (SABR)
RadiationSABR 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 radiotherapy
RadiationRadiotherapy 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).
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Control Arm (Palliative Radiotherapy)Active comparator 1 intervention
Group B: Experimental Arm (SABR)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
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 months2
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.
Time frame
12 and 24 months3
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).
Time frame
6 weeksSecondary outcomes
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);
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 months2
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;
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 months3
Comparing the anatomic sites of disease progression
A list of anatomical sites at which there are new or progressing lesions will be collected
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 months4
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)
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 monthsSponsors and contacts
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Source ClinicalTrials.gov