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

Renal Cell Carcinoma Clinical Trial

— METHEOS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02747173
• Other study ID #: SOG-ANG-2014-01
• Status: Terminated
• First received: April 23, 2015
• Last updated: April 25, 2018
• Start date: October 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Spanish Oncology Genito-Urinary Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Neoplasm Metastasis
• Renal Cell Carcinoma

Locations

Country	Name	City	State
Spain	Consorcio Hospitalario Parc Tauli	Barcelona
Spain	Complejo Hospitalario de León	Leon
Spain	Hospital Univ Lucus Augusti	Lugo
Spain	Complejo Hospitalario de Ourense	Ourense
Spain	Hospital Universitario central de Asturias	Oviedo	Asturias
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital de Donostia	San Sebastián	Guipuzcoa
Spain	Complejo Hospitalario Univ de Santiago de Compostela	Santiago de Compostela	La Coruña
Spain	Hospital Universitario La Fe	Valencia
Spain	Instituto Valenciano de Oncologia	Valencia
Spain	Complejo Hospitalario Univ de Vigo	Vigo	Pontevedra
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Oncology Genito-Urinary Group	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival	Assess the efficacy of TKI in patients with RCC with bone metastases.	An average of 12 months
Secondary	Objective response rate	Assess the efficacy of TKI in patients with RCC with bone metastases.	An average of 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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