Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
Conditions
Interventions
Intervention1: Neoadjuvant pazopanib in RCC unsuitable for PN: All localized RCC patients diagnosed/ proven with contrast enhanced computed tomography (CECT ) which are not suitable for PN due to size
Sponsors
AIIMS Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Expected reduction of GFR less than 30 ml/minute/1.73 m2 after RN or PN and/or 2) Not suitable for PN due to large tumors size (4 - 7cm) and/or high complexity (R.E.N.A.L. score 10 to 12) and/or hilar tumors location. 3. Histological verification of cRCC. 4. Non- metastatic disease 5.Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to pazopanib 2. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. 3. Hypertension [defined as systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg in spite of optimal medical management.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether patients with cRCC who are otherwise not amenable to PN can be down-staged with 8 weeks of pazopanib and rendered amenable to PN. Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To measure the decrease in tumor size in centimeter , volume in cc and RENAL Score after 8 weeks of pazopanib therapy. 2.To determine the surgical safety of pazopanib on wound healing and post-operative thromboembolic events . Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactSwarnendu Mandal
AIIMS Bhubaneswar
Outcome results
None listed