Renal Cell Carcinoma
Conditions
Keywords
metastatic, bone metastases
Brief summary
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
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.
Interventions
None listed
Sponsors
Pfizer
Spanish Oncology Genito-Urinary Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess bone biomarkers in response to TKI | Every 3 months until an average of 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | An average of 12 months | Assess the efficacy of TKI in patients with RCC with bone metastases. |
| Measurements in time of bone metastases in RCC using whole body magnetic resonance and bone scintigraphy | Every 3 months until an average of 12 months | 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 |
| Change and correlation of magnetic resonance and CT results in the assessment of global disease response to TKI. Using RECIST and MASS criteria | Every 3 months until an average of 12 months | Compare globally the magnetic resonance and CT results in the assessment of disease response to TKI using RECIST and MASS criteria |
| Quality of life of patients with RCC and bone metastases throughout the study period using the FSI-15 | Every 3 months until an average of 12 months | 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) |
| Progression free survival | An average of 12 months | Assess the efficacy of TKI in patients with RCC with bone metastases. |
| Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period | every week until an average of 12 months | Assess the efficacy of TKI in the improvement of pain produced by bone metastases assessing the use of analgesics. |
| Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period using the NPR scale | every week until an average of 12 months | Assess the efficacy of TKI in the improvement of pain produced by bone metastases using the Numeric Pain Rating Scale |
| Assessment osteonecrosis of the jaw with use of biphosphonates or denosumab throughout the study period | every week until an average of 12 months | Risk of osteonecrosis of the jaw with use of biphosphonates or denosumab |
| Quality of life of patients with RCC and bone metastases throughout the study period using FACT-BP | Every 3 months until an average of 12 months | Assess the quality of life of patients with RCC and bone metastases using the FACT-BP questionnaire |
Countries
Spain
Outcome results
None listed