Prognostic Factor for Renal Cell Carcinoma (RCC) With Venous Tumor Thrombus

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01328691
First received: April 1, 2011
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

Renal cell carcinoma (RCC) has its propensity to invade the venous system, with extension into the renal vein and the inferior vena cava (IVC) in 23% and 7%, respectively. Despite advances in radiation, chemotherapy, and immunotherapy the reference standard for RCC with tumor thrombus remains surgical resection. However, the 5-year survival rate for patients who have RCC with venous tumor thrombus treated with radical nephrectomy and tumor thrombectomy is only 35% - 45%, despite the developments in surgical technique and perioperative care. Furthermore, even the 5-year survival rate for the patients without the evidence of nodal or distant metastasis at presentation is just 45% - 65%.

The outcome prediction for RCC remains controversial, and although many parameters have been tested for prognostic significance, only a few have achieved widespread acceptance in clinical practice. Currently, pathologic stage (T stage), lymph node status (N stage) and histologic grade represent the main prognostic variables in the patients with RCC and venous tumor thrombus. Accordingly, the American Joint Committee on Cancer (AJCC) TNM classification is regularly revised and, recently, a new 2009 AJCC TNM stage classification system has been proposed.

RCC is more prevalent in developed countries, such as Europe and North America. It is relatively less common in Asia; however, the incidence in these regions appears to have risen over the past decade. Recently, a few series have suggested that racial or ethnic differences in survival persist after controlling for age and stage in some cancers. In the case of renal cell carcinoma, it has been demonstrated that the malignancy diagnosed in various ethnic groups had different clinical characteristics: the presenting symptoms, the course of disease, and the outcome after standard treatment varied significantly between patients of Caucasian, Hispanic, African-American, and Asian backgrounds. A recent study has reported that race as well as established factors has an impact on survival in patients with RCC and Asian Pacific Islander ethnicity was predictive of improved overall or cancer specific survival.

Up to date, there was sparse data on surgical outcome and prognostic factors of survival after radical nephrectomy and thrombectomy in an Asian population with RCC and venous tumor thrombus, while most studies have been performed in Western countries. The aim of the present study was to address the surgical outcome after radical nephrectomy with thrombectomy and to evaluate the prognostic factors influencing on survival in Korean patients with RCC and tumor thrombus extension into renal vein or IVC, labeled as T3a and T3b-c by the newly revised 2009 AJCC TNM staging system, respectively.


Condition
Carcinoma, Renal Cell
Thrombus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Factors for Korean Patients With Renal Cell Carcinoma and Venous Tumor Thrombus Extension: Application of the New 2009 TNM Staging System

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Cancer-specific survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence-free survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: March 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

From Feburary 1988 to April 2009, a total of 118 patients with RCC and venous tumor thrombus who underwent radical nephrectomy and thrombectomy at our tertiary referal center

Criteria

Inclusion Criteria:

  • age ≥ 18 years old
  • patients with RCC and venous tumor thrombus who underwent radical nephrectomy and thrombectomy

Exclusion Criteria:

  • von Hippel-Lindau disease
  • tuberous sclerosis syndrome
  • Wilms' tumor
  • synchronous bilateral tumor
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01328691

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Cheol Kwak, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Cheol Kwak / M.D., Ph.D., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01328691     History of Changes
Other Study ID Numbers: MCCho5
Study First Received: April 1, 2011
Last Updated: May 9, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Carcinoma, Renal Cell
thrombus
body mass index
grade

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Thrombosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014