A CpG-methylation-based Assay for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment

Not Applicable

Not yet recruiting

• Conditions: Renal Neoplasms; Targeted Molecular Therapy
• Interventions: Drug: sunitinib

• Registration Number: NCT02688491
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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 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.

Detailed Description

The investigators' CpG-methylation-based assay contains 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）. The investigators evaluate the CpG methylation status of surgical specimens using pyrosequencing and calculate their risk score\[risk score=(0.0066×PITX1)+(0.0034×FOXE3)-(0.027×TWF2) -(0.018×EHBP1L1)-(0.03×RIN1)\], risk score ≥-0.1 as assay-defined high risk status and risk score\<-0.1 as assay-defined low risk status. The investigators randomly assign assay-defined high risk patients of stage III ccRCC into intervention group and control group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation. Primary endpoint is the disease free survival and overall survival.

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25
• Study Start: 2016-07
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 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

• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (Intervention group,sunitinib)	sunitinib	Beginning 4-12 weeks following radical nephrectomy, patients receive sunitinib malate PO QD for 4 weeks

Primary Outcome Measures

Name	Time	Method
Disease free survival	From the date of registration to up to10 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	From the date of registration to up to10 years