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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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<br>|
| No Intervention: B<br>Patients with radical nephrectomy are observed without intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tyrosine kinase inhibitors (TKIs), target therapy