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Trial Title:
Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
NCT ID:
NCT06467097
Condition:
Kidney Neoplasm
Conditions: Official terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT(Stereotatic Body Radiation Therapy)
Description:
Patients will receive treatment for one to two weeks, one to five times per region.
Arm group label:
B group
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Won Park, M.D., Ph.D.
Phone:
+82-2-3410-2616
Email:
wonro.park@samsung.com
Start date:
April 16, 2024
Completion date:
February 13, 2031
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06467097
