Back to resultsMultimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment
Primary Purpose
Renal Cell Carcinoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring target therapy, tyrosine kinase inhibitors (TKIs)
Eligibility Criteria
Inclusion Criteria: The informed consent has been obtained from the patient. With confirmed diagnosis of stage III clear cell renal cell carcinoma With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score. The patient receive no anti-cancer treatment before primary surgery. The patient receive radical operation for renal cancer with negative margin. Exclusion Criteria: Patients who have previously received neoadjuvant therapy With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. With bad compliance or contraindication to enrollment. Pregnant woman or lactating woman. With contraindication to receive adjuvant targeted therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
sunitinib 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
Patients with radical nephrectomy are observed without intervention
Outcomes
Primary Outcome Measures
Disease free survival
Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.
Secondary Outcome Measures
Overall survival
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.
Full Information
NCT ID
NCT06032728
First Posted
August 30, 2023
Last Updated
September 11, 2023
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT06032728
Brief Title
Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment
Official Title
A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on Multimodal Recurrence Scoring System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2033 (Anticipated)
Study Completion Date
October 1, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Whether patients with stage III clear cell renal cell carcinoma (ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a multimodal recurrence scoring system that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group. Disease free survival and overall survival are the end points of observation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
target therapy, tyrosine kinase inhibitors (TKIs)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
488 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
sunitinib 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
Arm Title
B
Arm Type
No Intervention
Arm Description
Patients with radical nephrectomy are observed without intervention
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
The investigators randomly assign multimodal recurrence scoring system defined high risk patients of stage III ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation
Primary Outcome Measure Information:
Title
Disease free survival
Description
Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.
Time Frame
From the date of registration to up to 10 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
From the date of registration to up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The informed consent has been obtained from the patient.
With confirmed diagnosis of stage III clear cell renal cell carcinoma
With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
The patient receive no anti-cancer treatment before primary surgery.
The patient receive radical operation for renal cancer with negative margin.
Exclusion Criteria:
Patients who have previously received neoadjuvant therapy
With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
With bad compliance or contraindication to enrollment.
Pregnant woman or lactating woman.
With contraindication to receive adjuvant targeted therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-huan Wei, MD
Phone
+8613580314021
Email
342729243@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment
We'll reach out to this number within 24 hrs