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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • sunitinib

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: A (Intervention group,sunitinib)Experimental treatment 1 intervention
Group B: B(observation group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Disease free survival

Time frame
From the date of registration to up to10 years

Secondary outcomes

1

Overall survival

Time frame
From the date of registration to up to10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: