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

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sunitinib

Drug

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 outcomes

Disease free survival

Time frame: 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 outcomes

Overall survival

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin-huan Wei, MD

CONTACT

[email protected]

+8613580314021

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2033
Study completion: 2033
First posted: Sep 13, 2023
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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