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

April 25, 2018 updated by: Spanish Oncology Genito-Urinary Group

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08208
        • Consorcio Hospitalario Parc Tauli
      • Leon, Spain, 24071
        • Complejo Hospitalario de León
      • Lugo, Spain, 27003
        • Hospital Univ Lucus Augusti
      • Ourense, Spain, 32005
        • Complejo Hospitalario de Ourense
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain, 20080
        • Hospital de Donostia
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Complejo Hospitalario Univ de Santiago de Compostela
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital De Navarra
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • Complejo Hospitalario Univ de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
RCC patients with bone metastases
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess bone biomarkers in response to TKI
Time Frame: 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.
Every 3 months until an average of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: An average of 12 months
Assess the efficacy of TKI in patients with RCC with bone metastases.
An average of 12 months
Objective response rate
Time Frame: An average of 12 months
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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)
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
Time Frame: 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
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
Time Frame: 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.
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
Time Frame: 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
every week until an average of 12 months
Assessment osteonecrosis of the jaw with use of biphosphonates or denosumab throughout the study period
Time Frame: every week until an average of 12 months
Risk of osteonecrosis of the jaw with use of biphosphonates or denosumab
every week until an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

Pfizer

Investigators

  • Principal Investigator: Sergio Vazquez, MD, Hospital Univ Lucus Augusti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOG-ANG-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Cell Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe