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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06032728
• Other study ID #: FirstSunYatSen
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2033

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Jin-huan Wei, MD
• Phone: +8613580314021
• Email: 342729243[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 488
• Est. completion date: October 1, 2033
• Est. primary completion date: October 1, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Recurrence
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the date of registration to up to 10 years
Secondary	Overall survival	Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.	From the date of registration to up to 10 years