SMC Radiation Oncology SABR Cohort for Oligometastasis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSamsung Medical Center

About this trial

The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer.

The main questions it aims to answer are:

1. oncologic outcomes (progression-free survival, local failure rate), 2. patient-reported outcomes, 3. physician-assessed toxicity, and 4. dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Performance status (ECOG PS) 0-2

Diagnosed with metastatic disease

Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)

Disqualifiers

Patient with a history of prior radiotherapy to the site planned for SABR

Patients with concomitant brain metastases

Trial population

Cancer patients who are Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)

    Radiation

    Stereotactic body radiotherapy (SABR) using photon or proton beams will be delivered per standard practice (1-5 fractions).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Progression-free survival

Time from the start of stereotactic body radiotherapy (SABR) to the first documented event of local failure, distant failure, death from any cause, or last follow-up, whichever occurs first.

Time frame
From start of SABR to the earliest of local failure, distant failure, death, or last follow-up. It will be measured at 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
2

Physician assessed toxicity

Evaluated by treating physician based on CTCAE ver 5.0

Time frame
1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
3

Patient-reported outcome

It will be measured by PRO-CTCAE coreset 12.

Time frame
1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
4

Local failure

Local regrowth or progression at the site of SABR.

Time frame
1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.