Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sunitinib.
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Disease free survival [Time frame: From the date of registration to up to 10 years]
Secondary outcome measures (1)
- Overall survival [Time frame: From the date of registration to up to 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06032728 · FirstSunYatSen