About this trial
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 assay consisting of 5 CpGs: cg00396667(PITX1), cg18815943 (FOXE3), cg03890877(TWF2), cg07611000 (EHBP1L1)and cg14391855(RIN1)that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The informed consent has been obtained from the patient.
With confirmed diagnosis of stage III clear cell renal cell carcinoma
With moderate/good ECOG health rating (PS): 0-1 score.
The patient receive no anti-cancer treatment before primary surgery.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
sunitinib
DrugThe investigators randomly assign assay-defined high risk patients of stageIII ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation.
Treatment groups
Trial outcomes
Primary outcomes
Disease free survival
Secondary outcomes
Overall survival
Locations
Sponsors and contacts
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First Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Xi'an Jiaotong University
Collaborator
Yantai Yuhuangding Hospital
Collaborator
Sun Yat-sen University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: