Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques

Spanish Oncology Genito-Urinary Group4 enrolled

Overview

Prospective observational study to assess bone predictive biomarkers for TKI response in RCC patients with bone metastasis and HRQoL with TKI in these patients as well as the sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and versus CT in the assessment of metastatic lesions at bone level and at other sites.

Prospective observational study to assess: * Bone predictive biomarkers for tyrosine kinase inhibitor (TKI) response in renal cell carcinoma (RCC) patients with bone metastasis - Health Related Quality of Life (HRQoL) with TKI * Comparison of the sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and versus Computerized tomography (CT) in the assessment of metastatic lesions at bone level and at other sites.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Renal Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of a stage IV renal cell carcinoma with confirmed presence of bone metastases, subsidiary of treatment with an TKI in first line * 18 years old or more * Life expectancy \> 12 weeks * Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 - 2 * Capability of understanding the study and completing the numerical pain scale, diary of analgesics and Quality of Life forms * Patient who has given informed consent * Adequate renal, hepatic and hematologic functions Exclusion Criteria: * Pregnancy, breastfeeding or fertile patients who do not use adequate contraceptive methods * Non-clear cell histology * Non irradiated brains metastases * Symptomatic brain metastases * Inability to undergo any of the medical tests of the study * A history of breast cancer or melanoma. Other tumors are accepted as long as the patients has been for at least 5 years free of disease * Synchronic diagnosis of another neoplasm * Presence of an active infection * Any decompensated disease or metabolic disorder * Cardiac events or pulmonary embolism in the 12 months previous to inclusion

Locations (12)

Hospital de Donostia

San Sebastián, Guipuzcoa, Spain

Complejo Hospitalario Univ de Santiago de Compostela

Santiago de Compostela, La Coruña, Spain

Hospital de Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Assess bone biomarkers in response to TKI

Assess the predictive value to TKI of bone biomarkers (bone formation BAP, P1NP, OPG and osteocalcin, and bone resorption biomarkers CTX) in patients with RCC with bone metastases.

Time frame: Every 3 months until an average of 12 months

Secondary Outcomes

Progression free survival

Assess the efficacy of TKI in patients with RCC with bone metastases.

Time frame: An average of 12 months

Objective response rate

Assess the efficacy of TKI in patients with RCC with bone metastases.

Time frame: An average of 12 months

Measurements in time of bone metastases in RCC using whole body magnetic resonance and bone scintigraphy

Comparison of the sensibility and specificity of whole body magnetic resonance and bone scintigraphy in the detection of metastases and response assessment of bone metastases in RCC

Time frame: Every 3 months until an average of 12 months

Change and correlation of magnetic resonance and CT results in the assessment of global disease response to TKI. Using RECIST and MASS criteria

Compare globally the magnetic resonance and CT results in the assessment of disease response to TKI using RECIST and MASS criteria

Time frame: Every 3 months until an average of 12 months

Quality of life of patients with RCC and bone metastases throughout the study period using the FSI-15

Assess the quality of life of patients with RCC and bone metastases using the 15 item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-15)

Time frame: Every 3 months until an average of 12 months

Data from ClinicalTrials.gov

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