Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06032728

Collaborator

(none)

488

Enrollment

Arms

120

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Drug: Sunitinib	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

488 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2033

Anticipated Study Completion Date :

Oct 1, 2033

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 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.	Drug: Sunitinib 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
No Intervention: B Patients with radical nephrectomy are observed without intervention

Arm

Intervention/Treatment

Experimental: A

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.

Drug: Sunitinib

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

No Intervention: B

Patients with radical nephrectomy are observed without intervention

Outcome Measures

Primary Outcome Measures

Disease free survival [From the date of registration to up to 10 years]
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 [From the date of registration to up to 10 years]
Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.