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

NCT06467097 | Recruiting Phase 3

• 1 other identifier: SMC 2023-04-044
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Kidney Neoplasm

Outcome Measures

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

  One year after completion of enrollment

Secondary Outcomes (4)

• Local control rate for radiation therapy site at one year

  One year after radiation completion of each participant

• Grade 3 acute adverse event

  three to six months after study treatment

• Grade 3 chronic adverse event

  one year to three years after radiation completion

• Overall survival rate

  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

Study Arms (2)

A group

NO INTERVENTION

Only standard treatment is administered. The standard treatment includes targeted cancer therapy, immunotherapy, or monotherapy with each therapeutic agent.

B group

EXPERIMENTAL

This group receives concurrent partial nephrectomy radiotherapy for all metastatic lesions in addition to standard treatment.

Radiation: SBRT(Stereotatic Body Radiation Therapy)

Interventions

SBRT(Stereotatic Body Radiation Therapy) RADIATION

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

B group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients histologically diagnosed with clear cell carcinoma.
• Patients with ECOG performance status 0-1.
• Patients with normal major organ function and bone marrow function meeting specific criteria: WBC ≥ 2,000/μL, neutrophils ≥ 1,000/μL, platelets ≥ 50,000/μL.
• Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.
• Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.
• Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.
• Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.

You may not qualify if:

• 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.
• Patients with confirmed brain, peritoneal, or pleural metastases.
• Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.
• Patients who do not consent to participate in the study.
• Pregnant patients.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

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

CONTACT

+82-2-3410-2616; wonro.park@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Won Park, M.D., Ph.D.

Model Details: 1. Control group: A group that undergoes standard treatment alone for metastatic renal cell carcinoma. 2. Experimental group: A group that receives concurrent radiotherapy for all metastatic lesions in addition to standard treatment. We will compare the one-year progression-free survival rate between these groups, randomized from a random allocation point. Block randomization will be used, with 44 participants randomly assigned to each group using a random number table generated from a web-based program.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 20, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): February 13, 2031
• Study Completion (Estimated): February 13, 2031
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)