Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
Conditions
Interventions
Intervention1: Cabozantinib: 60mg PO OD will be administered for a duration of 1-year post nephrectomy.
Dose reductions:
First level: 40mg PO OD
Second level: 20mg PO OD
Control Intervention1: Observa
Sponsors
ACTREC, TMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed non-clear cell RCC 2. High-risk disease post-nephrectomy: pT2 G3-4, pT3 or pT4 any grade, or nodepositive (pN+), M0 or M1 NED 3. R0 resection within 12 weeks prior to randomization 4. ECOG 0 2 5. Adequate organ function
Exclusion criteria
Exclusion criteria: 1. Papillary Type 2 Non-clear cell RCC (FH deficient) 2. Renal medullary carcinoma 3. Prior systemic therapy for RCC 4. Uncontrolled hypertension 5. Recent major cardiovascular events within the past 3 months. 6. GI disorders affecting drug absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS)Timepoint: Up to 24 months post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) Safety and Tolerability Time to Recurrence Recurrence Patterns Quality of Life (QoL) Timepoint: Up to 48 months Up to 48 months Up to 48 months Up to 48 months Baseline, during treatment, & follow up | — |
Countries
India
Contacts
Public ContactDr Amit Joshi
The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed