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

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ClinicalTrials.gov Identifier: NCT02747173
Recruitment Status : Terminated
First Posted : April 21, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

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
Renal Cell Carcinoma

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
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 : October 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: An average of 12 months ]
    Assess the efficacy of TKI in patients with RCC with bone metastases.

  2. Objective response rate [ Time Frame: 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 [ 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

  4. 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

  5. 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)

  6. 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

  7. 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.

  8. 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

  9. 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


Biospecimen Retention:   Samples Without DNA
Blood plasma samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747173


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

Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT02747173     History of Changes
Other Study ID Numbers: SOG-ANG-2014-01
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Keywords provided by Spanish Oncology Genito-Urinary Group:
metastatic, bone metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Carcinoma, Renal Cell
Neoplastic Processes
Neoplasms
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases