NCT01041482

Brief Summary

A one-arm,open,multi-center study, to evaluate sorafenib (400mg twice daily ) as a adjuvant to prevent recurrence of RCC(renal cell carcinoma) patients after radical nephrectomy with a high-risk of recurring. To observe disease-free survival and the survival rate in 3 years,5 years. The purpose of this study is:

  • To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.
  • To observe the incidence of hand-foot skin reaction (HFSR) after the Urea (10% or 5%) based cream intervention treatment. The primary end point is the disease-free survival(DFS).The secondary end point is overall survival(OS),the drug safety and tolerance, the occurrence of hand foot skin reaction(HFSR) at the week of 3,6,12,the skin toxicity(not include HFSR) higher than CTCAE(Common Terminology Criteria for Adverse Events) Grade 2 at the 12th week, the incidence of HFSR after the Urea (10% or 5%) based cream intervention treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 6, 2010

Status Verified

August 1, 2008

Enrollment Period

3 years

First QC Date

December 30, 2009

Last Update Submit

January 5, 2010

Conditions

Renal Cell Carcinoma

Keywords

sorafenibrenal cell carcinomadisease free survivalHand food skin reaction

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    November 2008-November 2013

Secondary Outcomes (1)

  • overall survival

    November 2008-November 2013

Study Arms (1)

sorafenib

EXPERIMENTAL

To study the efficacy of Sorafenib as an adjuvant therapy for reducing recurrence rate in locally advanced renal-cell carcinoma (RCC) after radical nephrectomy.

Drug: sorafenib

Interventions

sorafenibDRUG

sorafenib 400mg twice daily

sorafenib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preoperative Criteria
  • Renal local advanced renal cell carcinoma and be suitable to radical nephrectomy.
  • Tumor \>=7cm, the lymph nodes in metastasis can be resectable, the renal vein or inferior caval vein with metastatic thrombus can be resectable also, clinical staging\>=T2anyNMo.
  • Resectable tumor with multiple-lesion in ipsolateral kidney Enrolment Criteria
  • No distant metastasis.
  • Not undergoing any adjuvant or systematic anti-tumor therapy, such as chemotherapy, biotherapy or radiotherapy.
  • After the nephrectomy 4-12 weeks and should be recovery in the postoperative complications.
  • ECOG scores 0-1.
  • Referring to the Scoring Algorithm to Predict Metastasis after Radical Nephrectomy in Patients with clear cell renal cell carcinoma, all the patients score higher than 6. Metastatic lymph node with clinical diagnosis have been resected, all the resected specimen edge be negative in pathological detection.
  • The pathological diagnosis of renal cell carcinoma:
  • No remnant tumor with postoperative imaging screening with CT or MRI.
  • The liver and renal function, hemocytogenesis function meet the below criteria within the 4 weeks before the enrollment.
  • Granulocytes count \>1500/mm3
  • Blood platelet \>100000/mm3
  • Creatinine\<2 times of the upper of the reference value
  • +3 more criteria

You may not qualify if:

  • Other coincident carcinoma, but not including carcinoma in situ of cervix and basal cell epithelioma after radical therapy and bladder carcinoma superficially(Ta,Tis,T1) or carcinoma having been cured 3 years ago.
  • Cardiac dysrhythmia need agent intervention(not including β-receptor inhibitive or digoxin treatment), coronary heart disease, myocardial infarction occurred in the later 6 months, heart failure assessment higher than NYHA II
  • Seriously active infection with bacteria or fungus
  • HIV infection or HBV/HCV infection with IFN-a intervention.
  • Dysfunction in blood coagulation.
  • Epilepsia with drug treatment.
  • Those cannot take tablets orally.
  • Allogeneic organ transplantation.
  • Drug abuse or concomitant conditions such as psychologically or socially factors which may intervene the assessment.
  • Hypersensitiveness to the studying adjuvant or the trial-relevant drugs.
  • Pregnancy or lactation, pregnancy test must be negative within the 14 days before the trial beginning, either females or males must be contraceptive during the trial.
  • The following concomitant therapeutics must be excluded:
  • Anti-tumor agents, immunological or hormonal therapy
  • Radiotherapy
  • Biological therapeutics such as G-CSF or GM-CSF
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianhui Ma

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences, Doctor

CONTACT

01086108778

China Academy of Medical Sciences Jianhui Ma China Academy of Medical Sciences

CONTACT

01086108778

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2013

Last Updated

January 6, 2010

Record last verified: 2008-08

Locations

CN(1)