Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis Health Condition 2: null- Metastatic RCC Non Resectable HCC
Conditions
Interventions
None listed
Sponsors
Terry Fox Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Patients age > 18 yrs 1.Gender: male/female 2.Patients with Metastatic Renal cell carcinoma or Advanced Hepatocellular Carcinoma. 3. Patients who are sorafenib naive or those who are already on sorafenib without recurrent grade 2 or grade 3 HFSR over a period of 8 weeks or more on standard dose of sorafenib. 4. ECOG status 0 to 2. 5. Patients who are capable of providing written informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients simultaneously taking another anti- cancer agent or combination of anti-cancer agents known to cause hand foot syndrome 2.Patients with pre-existing dermatological condition affecting the hands or feet 3.Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To derive a mathematical model for sorafenib dosing based on the following co-variates to decrease the drug induced HFSR: 1. Genetic variation 2.Pharmacokinetics 3.Patient demographic characteristics like albumin, hemoglobin, ECOG statusTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the sensitivity, specificity, positive predictive value, negative predictive value; overall agreement of the model with the observed data.Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Manjunath Nookala
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), TMC
Outcome results
None listed