Clinical trial NCT02747173: Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Cell Carcinoma
Keywords: metastatic, bone metastases
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-04-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a diagnosis of a stage IV renal cell carcinoma with confirmed presence of bone metastases, subsidiary of treatment with an TKI in first line

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess bone biomarkers in response to TKI
timeFrame: Every 3 months until an average of 12 months
Secondary outcomes:
measure: Progression free survival
timeFrame: An average of 12 months
measure: Objective response rate
timeFrame: An average of 12 months
measure: Measurements in time of bone metastases in RCC using whole body magnetic resonance and bone scintigraphy
timeFrame: Every 3 months until an average of 12 months
measure: Change and correlation of magnetic resonance and CT results in the assessment of global disease response to TKI. Using RECIST and MASS criteria
timeFrame: Every 3 months until an average of 12 months
measure: Quality of life of patients with RCC and bone metastases throughout the study period using the FSI-15
timeFrame: Every 3 months until an average of 12 months
measure: Quality of life of patients with RCC and bone metastases throughout the study period using FACT-BP
timeFrame: Every 3 months until an average of 12 months
measure: Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period
timeFrame: every week until an average of 12 months
measure: Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period using the NPR scale
timeFrame: every week until an average of 12 months
measure: Assessment osteonecrosis of the jaw with use of biphosphonates or denosumab throughout the study period
timeFrame: every week until an average of 12 months
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario central de Asturias
state: Asturias
city: San Sebastián
country: Spain
facility: Hospital de Donostia
state: Guipuzcoa
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Univ de Santiago de Compostela
state: La Coruña
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Complejo Hospitalario Univ de Vigo
state: Pontevedra
city: Barcelona
country: Spain
facility: Consorcio Hospitalario Parc Tauli
city: Leon
country: Spain
facility: Complejo Hospitalario de León
city: Lugo
country: Spain
facility: Hospital Univ Lucus Augusti
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Univ Lucus Augusti
name: Sergio Vazquez, MD
role: PRINCIPAL_INVESTIGATOR
References: