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Stereotactic Radiotherapy Versus Palliative Conventional Radiotherapy for Oligoprogressive Metastatic Cancers

NCT06918951 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-12-15

No results posted yet for this study

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.

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.

Conditions

  • Oligoprogression
  • Oligometastatic Disease
  • OligoProgressive Metastatic Disease

Interventions

RADIATION

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

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).

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2030-06-01
Completion
2033-06-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918951 on ClinicalTrials.gov