Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSamsung Medical Center

About this trial

To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases.

Patients aged 20 to 80 years.

Patients with individual metastases ≤ 5 cm in longest diameter.

Patients with primary tumors surgically removed or scheduled for surgery.

Disqualifiers

Patients with total bilirubin > 3.6 mg/dL.

Patients with AST >160 U/L, ALT > 165 U/L.

Patients unable to maintain position for partial nephrectomy radiotherapy.

Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SBRT(Stereotatic Body Radiation Therapy)

    Radiation

    Patients will receive treatment for one to two weeks, one to five times per region.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: A groupNo intervention 0 interventions
Group B: B groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year progression-free survival rate

Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group

Time frame
One year after completion of enrollment

Secondary outcomes

1

Local control rate for radiation therapy site at one year

Compare Local control rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group

Time frame
One year after radiation completion of each participant
2

Grade 3 acute adverse event

Compare acute adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group

Time frame
three to six months after study treatment
3

Grade 3 chronic adverse event

Compare chronic adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group

Time frame
one year to three years after radiation completion
4

Overall survival rate

Compare Overall survival rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Other outcomes

Sponsors and contacts

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