Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

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Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients

Condition: Complete Remission in Renal Cell Carcinoma

Intervention:

  • Drug: sunitinib
  • Drug: sunitinib

Purpose: This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions : Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01934452

Sponsor: Pfizer

Primary Outcome Measures:

  • Measure: Characteristics of study patients
  • Time Frame: Baseline up to 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: mRCC patients with CR
  • Time Frame: Baseline up to 36 months
  • Safety Issue:
  • Measure: Presence (rate) or Absence of blood biomarkers
  • Time Frame: Baseline up to 36 months
  • Safety Issue:
  • Measure: Presence (rate) or Absence of blood biomarkers
  • Time Frame: Baseline up to 36 months
  • Safety Issue:

Estimated Enrollment: 120

Study Start Date: May 21, 2015

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Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: All

Inclusion Criteria:

  • Patients with metastatic renal cell carcinoma, histopathologically confirmed
  • Treated with sunitinib according to Smpc
  • For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA)
  • For controls: Life expectancy > 3 months No prior Sunitinib treatment
  • Patient >18 years

Exclusion Criteria:

  • Sunitinib administered in a non-approved label
  • For cases: CR occurring without sunitinib treatment
  • For controls: Prior systemic treatment

Contact:

  • Pfizer CT.gov Call Center
  • 1-800-718-1021

Locations:

  • CHU de la Timone
  • Marseille Cedex 5 13335 France
  • CHU Strasbourg
  • Strasbourg Cedex 67091 France
  • CHRU HOTEL DIEU – Service Urologie
  • Angers Cedex 49933 France
  • C.H.U Morvan
  • Brest 29000 France
  • Clinique Victor Hugo
  • Le Mans 72015 France
  • Institut Paoli-Calmettes
  • Marseille Cedex 09 13273 France
  • Institut Paoli-Calmettes / Hôpital de jour
  • Marseille Cedex 9 13273 Cedex 9 France
  • Hopital Timone Adultes
  • Marseille Cedex 13385 France
  • CRLC Val d’Aurelle
  • Montpellier cedex 05 34295 France
  • Hopital Europeen Georges Pompidou
  • Paris Cedex 15 75908 France
  • Centre Hospitalier Lyon Sud
  • Pierre Bénite Cedex 69495 France
  • Clinique Chirurgicale de l’Orangerie, Chiliotherapie
  • Strasbourg 67010 France
  • Centre Alexis Vautrin
  • Vandoeuvre les Nancy 54511 France
  • Institut Gustave Roussy
  • Villejuif Cedex 94805 France

View trial on ClinicalTrials.gov

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