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

September 11, 2023 updated by: Jun-Hang Luo, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

488

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of registration to up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of registration to up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2033

Study Completion (Estimated)

October 1, 2033

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstSunYatSen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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