Health Condition 1: N00-N99- Diseases of the genitourinary system
Conditions
Interventions
Intervention1: Local + Systemic Rx: 1) Local therapy (cytoreductive nephrectomy or SBRT to Kidney) the first-line systemic therapy will be continued.
2) Metastasis directed therapy allowed (RT,RFA, Me
Sponsors
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Kharghar, TMC
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age above 18 years 2) ECOG PS 0 to 2 3)Histologically confirmed clear cell RCC 4) Radiologically confirmed metastatic disease 4) Completed 6 months of first line systemic therapy, with radiological assessment at 6 months demonstrating complete response (CR) partial response (PR) or stable disease (SD). 6) Adequate organ and marrow function
Exclusion criteria
Exclusion criteria: 1) Non-clear cell RCC 2)Prior systemic therapy for metastatic RCC 3)Prior local therapy (prior nephrectomy or SBRT to kidney) 4)Inability to undergo nephrectomy in view of Uncontrolled or significant co-morbidities. 5) Clinically significant coagulopathy 6) Active or uncontrolled infection 7) Auto-immune disease on systemic immunosuppression (Prednisolon more than 10mg per day) 8)Prior history of malignancy 9) Pregnancy or Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) progression-free survival (PFS) Timepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival (OS) 2) objective response rate (ORR) 3) safety and tolerability 4) Locoregional Control 5) Health-Related Quality of Life (HRQoL)Timepoint: one year | — |
Countries
India
Contacts
Public ContactDr Aditya Dhanawat
Advanced Centre for Treatment Research and Education in Cancer (ACTREC),
Outcome results
None listed