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

NCT ID: NCT06467097

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2031-02-13

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.

Detailed Description

Various institutions are attempting to use locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, accompanied by a few metastases. Research findings have indicated that high-dose locoregional radiotherapy can suppress disease progression, potentially prolonging the interval for additional systemic therapy; however, whether the addition of locoregional radiotherapy in cases of renal cell carcinoma with oligometastases demonstrates superior oncologic outcome compared to standard systemic therapy alone has yet to be established. Therefore, a randomized phase III study is being conducted 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

B group

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

Group Type: EXPERIMENTAL

SBRT(Stereotatic Body Radiation Therapy)

Intervention Type: RADIATION

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

Interventions

SBRT(Stereotatic Body Radiation Therapy)

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients aged 20 to 80 years.

3. Patients with individual metastases ≤ 5 cm in longest diameter.

4. Patients with primary tumors surgically removed or scheduled for surgery.

5. Patients histologically diagnosed with clear cell carcinoma.

6. Patients with ECOG performance status 0-1.

7. 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.

8. Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.

9. Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.

10. Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.

11. Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.

Exclusion Criteria

1. Patients with total bilirubin > 3.6 mg/dL.

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

3. Patients unable to maintain position for partial nephrectomy radiotherapy.

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

5. Patients with confirmed brain, peritoneal, or pleural metastases.

6. Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.

7. Patients who do not consent to participate in the study.

8. Pregnant patients.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won Park

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

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

Role: CONTACT

wonro.park@samsung.com

+82-2-3410-2616

Facility Contacts

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

Role: primary

wonro.park@samsung.com

+82-2-3410-2616

Other Identifiers

SMC 2023-04-044

Identifier Type: -

Identifier Source: org_study_id