Carcinoma, Renal Cell Clinical Trial
Official title:
Prognostic Factors for Korean Patients With Renal Cell Carcinoma and Venous Tumor Thrombus Extension: Application of the New 2009 TNM Staging System
Verified date | May 2011 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cancer-specific survival | Five years | Yes | |
Secondary | Recurrence-free survival | Five years | Yes |
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