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

NCT ID: NCT02688491

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2026-07-31

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.

Conditions

Renal Neoplasms; Targeted Molecular Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

A (Intervention group,sunitinib)

Beginning 4-12 weeks following radical nephrectomy, patients receive sunitinib malate PO QD for 4 weeks

Group Type: EXPERIMENTAL

sunitinib

Intervention Type: DRUG

The 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.

B(observation group)

Patients with radical nephrectomy are observed without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

sunitinib

The 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.

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Jun-Hang Luo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun-Hang Luo, MD

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Central Contacts

Jinhuan Wei, MD

Role: CONTACT

342729243@qq.com

+8613580314021

Other Identifiers

[2016]015

Identifier Type: -

Identifier Source: org_study_id