Actively Recruiting

Phase 3
Age: 20Years - 80Years
All Genders
NCT06467097

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

Led by Samsung Medical Center · Updated on 2024-06-20

88

Participants Needed

1

Research Sites

356 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with metastatic renal cell carcinoma having 5 or fewer metastases and 3 or fewer metastatic organs, including new, recurrent, or induced metastases
  • Aged between 20 and 80 years
  • Individual metastases measuring 5 cm or less in longest diameter
  • Primary tumor surgically removed or scheduled for surgery
  • Histologically confirmed clear cell carcinoma
  • ECOG performance status of 0 or 1
  • Normal major organ and bone marrow function with WBC ≥ 2,000/µL, neutrophils ≥ 1,000/µL, and platelets ≥ 50,000/µL
  • Able to understand and voluntarily sign informed consent
  • Agree to use contraception from consent signing until 1 year after last systemic therapy
  • Breastfeeding women agree to stop breastfeeding for at least 5 months after last systemic therapy
  • Presence of visible tumors outside the surgical removal area for metastatic lesions
Not Eligible

You will not qualify if you...

  • Total bilirubin level above 3.6 mg/dL
  • AST levels above 160 U/L or ALT levels above 165 U/L
  • Unable to maintain position for partial nephrectomy radiotherapy
  • Previous radiotherapy to metastatic renal cell carcinoma or surrounding areas
  • Presence of brain, peritoneal, or pleural metastases
  • Diagnosed with another solid tumor treated within 2 years or with residual lesions
  • Refusal to consent to participate in the study
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

W

Won Park, M.D., Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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