Renal Cell Carcinoma
Conditions
Keywords
target therapy, tyrosine kinase inhibitors (TKIs)
Brief 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.
Interventions
DRUGSunitinib
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
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
Contacts
Primary ContactJin-huan Wei, MD
Outcome results
None listed