NCT02688491

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jul 2016

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Jul 2016Jul 2026

First Submitted

Initial submission to the registry

February 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

10 years

First QC Date

February 18, 2016

Last Update Submit

February 24, 2016

Conditions

Renal NeoplasmsTargeted Molecular Therapy

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    From the date of registration to up to10 years

Secondary Outcomes (1)

  • Overall survival

    From the date of registration to up to10 years

Study Arms (2)

A (Intervention group,sunitinib)

EXPERIMENTAL

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

Drug: sunitinib

B(observation group)

NO INTERVENTION

Patients with radical nephrectomy are observed without intervention

Interventions

sunitinibDRUG

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.

A (Intervention group,sunitinib)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jun-Hang Luo, MD

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Jinhuan Wei, MD

CONTACT

+8613580314021342729243@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 23, 2016

Study Start

July 1, 2016

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 25, 2016

Record last verified: 2016-02