Systemic Treatment Alone Versus Systemic Treatment Plus R... | NCT06467097

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

NCT06467097

Sponsor

Samsung Medical Center

Status

Recruiting

Last Update Posted

Jun 20, 2024Actual

Enrollment

88Estimated

Phase

Phase 3

Conditions

Kidney Neoplasm

Interventions

SBRT(Stereotatic Body Radiation Therapy)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2024Actual

Primary Completion Date

Feb 13, 2031Estimated

Completion Date

Feb 13, 2031Estimated

First Submitted Date

Jun 11, 2024

First Submission Date that Met QC Criteria

Jun 18, 2024

First Posted Date

Jun 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2024

Last Update Posted Date

Jun 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SBRT(Stereotatic Body Radiation Therapy)	Radiation	Patients will receive treatment for one to two weeks, one to five times per region.	B group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	One year after radiation completion of each participant
Grade 3 acute adverse event

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Won Park, M.D., Ph.D.	Contact	+82-2-3410-2616		wonro.park@samsung.com

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		06351	South Korea

ID	Term
D007680	Kidney Neoplasms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Intervention Model Description

Control group: A group that undergoes standard treatment alone for metastatic renal cell carcinoma.
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.