Predictors of Hand Foot skin rash in patients with sorafebib
Not Applicable
- Conditions
- Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvisHealth Condition 2: null- Metastatic RCCNon Resectable HCC
- Registration Number
- CTRI/2017/10/009959
- Lead Sponsor
- Terry Fox Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To derive a mathematical model for sorafenib dosing based on the following co-variates <br/ ><br>to decrease the drug induced HFSR: <br/ ><br> <br/ ><br>1. Genetic variation <br/ ><br>2.Pharmacokinetics <br/ ><br>3.Patient demographic characteristics like albumin, hemoglobin, ECOG statusTimepoint: 2 years
- Secondary Outcome Measures
Name Time Method To determine the sensitivity, specificity, positive predictive value, negative predictive value; overall agreement of the model with the observed data.Timepoint: 2 years