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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study to Assess Bone Biomarkers for TKI Response in RCC Patients With Bone Metastasis and HRQoL in These Patients as Well as Comparing Whole Body MRI vs. Bone Scintigraphy and vs. CT in the Assessment of Metastatic Lesions

Conditions
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Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RCC patients with bone metastases<br>Patients will receive the standard TKI treatment for first line treatment naive metastatic RCC. Sunitinib or pazopanib as decided by the investigator. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Every 3 months until an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Assess the efficacy of TKI in patients with RCC with bone metastases. | An average of 12 months | 
| Objective response rate | Assess the efficacy of TKI in patients with RCC with bone metastases. | 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 | 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 | 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) | Every 3 months until an average of 12 months | 
| Quality of life of patients with RCC and bone metastases throughout the study period using FACT-BP | Assess the quality of life of patients with RCC and bone metastases using the FACT-BP questionnaire | Every 3 months until an average of 12 months | 
| Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period | Assess the efficacy of TKI in the improvement of pain produced by bone metastases assessing the use of analgesics. | every week until an average of 12 months | 
| Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period using the NPR scale | Assess the efficacy of TKI in the improvement of pain produced by bone metastases using the Numeric Pain Rating Scale | every week until an average of 12 months | 
| Assessment osteonecrosis of the jaw with use of biphosphonates or denosumab throughout the study period | Risk of osteonecrosis of the jaw with use of biphosphonates or denosumab | every week until an average of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, bone metastases