Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib


Condition: Metastatic Renal Cell Carcinoma

Intervention:

  • Procedure: Nephrectomy
  • Other: Sunitinib alone

Purpose: The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00930033

Sponsor: Assistance Publique - Hôpitaux de Paris

Primary Outcome Measures:

  • Measure: The primary endpoint is overall survival.
  • Time Frame: starting at 4 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria
  • Time Frame: Starting at 4 months
  • Safety Issue:
  • Measure: Clinical benefit (complete response, partial or stable for at least 12 weeks).
  • Time Frame: Starting at 4 months
  • Safety Issue:
  • Measure: Progression-Free Survival
  • Time Frame: Starting at 4 months
  • Safety Issue:
  • Measure: Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy
  • Time Frame: Starting at 4 months
  • Safety Issue:
  • Measure: Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy
  • Time Frame: Starting at 4 months
  • Safety Issue:
  • Measure: Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy
  • Time Frame: Starting at 4 months
  • Safety Issue:

Estimated Enrollment: 452

Study Start Date: September 2009

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • age ≥ 18 years
  • ECOG Performance Status 0
  • 1
  • Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma
  • Documented metastatic disease
  • Absence of prior systemic treatment for kidney cancer including AA
  • Tumour amenable to nephrectomy (partial or total) in the opinion of the patient's urologist. Patients presenting with an inferior vena cava thrombosis can be included.
  • Patients for which the indication of Sunitinib is considered according to the recommendations rules given by national health authorities of participating countries. The prescription of Sunitinib in the circumstances of the study is considered as a standard treatment.
  • Platelets > or = 100 x 109/L, haemoglobin >or = 9 g/dl, neutrophils >or = 1.5 x 109/L;
  • Bilirubin < or = 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT)< or = 2.5 times the upper normal limit (UNL) or < or = 5 times UNL for patients with liver metastases
  • Patients of child bearing age should use contraceptive methods
  • Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned.
  • Life expectancy ≥ 3 months
  • Written informed consent
  • Patient without brain metastases or with radiotherapy or surgery treated brain metastases without progression into 6 weeks and non treated by corticoid
  • Patient non treated by anticoagulants excepted HBPM

Exclusion Criteria:

  • Prior systemic treatment for kidney cancer (including Anti Angiogenic)
  • Bilateral kidney cancer
  • Pregnant or breast feeding women
  • Acute coronary syndrome or episode of myocardial infarction or severe or unstable angina within the last 6 months as well as severe diabetes with severe peripheral arteriopathy or deep phlebitis not treated with low molecular weight heparin or arterial thrombosis within the last 3 months
  • Patients being treated with antivitamin K with curative intent (please note that patients being treated with low molecular weight heparin can be included)
  • Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry
  • Symptomatic or untreated brain metastases (patients with brain metastases that have been treated by radiotherapy or surgery and have stable disease within 6 weeks, and are not requiring treatment with corticosteroids can be included)
  • Previous history of gastric disease or malabsorption, syndrome compromising the absorption of Sunitinib
  • Experimental treatment within the 28 days preceding inclusion
  • Other cancer within the previous 5 years (except for insitu skin carcinoma and treated localised prostate cancer with undetectable PSA)
  • Patient has received treatment with IV biphosphonate

Location:

  • Hopital Necker
  • Paris 75015 France

View trial on ClinicalTrials.gov


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