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

Spanish Oncology Genito-Urinary Group

Status: Terminated

Conditions: Renal Cell Carcinoma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02747173

SOG-ANG-2014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4 participants in 1 patient group

RCC patients with bone metastases

Description:

Patients will receive the standard TKI treatment for first line treatment naive metastatic RCC. Sunitinib or pazopanib as decided by the investigator.