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

Not Applicable

Not yet recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: Sunitinib

• Registration Number: NCT06032728
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-30
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Study Start: 2023-10-01
• Primary Completion: 2033-10-01
• Study Completion: 2033-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 488

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Sunitinib	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.