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

Sponsor
Spanish Oncology Genito-Urinary Group (Other)
Overall Status
Terminated
CT.gov ID
NCT02747173
Collaborator
Pfizer (Industry)
4
Enrollment
12
Locations
30
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    4 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Apr 1, 2018
    Actual Study Completion Date :
    Apr 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Progression free survival [An average of 12 months]

      Assess the efficacy of TKI in patients with RCC with bone metastases.

    2. Objective response rate [An average of 12 months]

      Assess the efficacy of TKI in patients with RCC with bone metastases.

    3. 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

    4. 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

    5. 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)

    6. 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

    7. 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.

    8. 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

    9. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario central de Asturias Oviedo Asturias Spain 33011
    2 Hospital de Donostia San Sebastián Guipuzcoa Spain 20080
    3 Complejo Hospitalario Univ de Santiago de Compostela Santiago de Compostela La Coruña Spain 15706
    4 Hospital de Navarra Pamplona Navarra Spain 31008
    5 Complejo Hospitalario Univ de Vigo Vigo Pontevedra Spain 36204
    6 Consorcio Hospitalario Parc Tauli Barcelona Spain 08208
    7 Complejo Hospitalario de León Leon Spain 24071
    8 Hospital Univ Lucus Augusti Lugo Spain 27003
    9 Complejo Hospitalario de Ourense Ourense Spain 32005
    10 Instituto Valenciano de Oncologia Valencia Spain 46009
    11 Hospital Universitario La Fe Valencia Spain 46026
    12 Hospital Miguel Servet Zaragoza Spain 50009

    Sponsors and Collaborators

    • Spanish Oncology Genito-Urinary Group
    • Pfizer

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Spanish Oncology Genito-Urinary Group
    ClinicalTrials.gov Identifier:
    NCT02747173
    Other Study ID Numbers:
    • SOG-ANG-2014-01
    First Posted:
    Apr 21, 2016
    Last Update Posted:
    Apr 26, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Spanish Oncology Genito-Urinary Group
    metastatic, bone metastases
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Apr 26, 2018