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Trial details

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Trial number(s)  :  EORTC 30073
KWF 2010-4887
Nickname  : SURTIME
Full title  : Randomized Phase III trial comparing immediate versus deferred nephrectomy in patients with synchronous metastatic renal cell carcinoma.
Phase  : III
Sample size  : 458
Tumor  : Urinary Tract
Subtumor  : Kidney
Patient selection  :

metastatic Renal Cell Cancer of clear-cell subtype with a resectable asymptomatic in situ primary

Objectives  :
  1. To determine if immediate versus deferred nephrectomy has an effect on disease control in patients with resectable, synchronous, metastatic renal cell carcinoma treated with sunitinib malate.
  2. To identify potential response criteria based on histopathology and molecular research on tumor tissue.
 
Inclusion criteria  :
  • histologically confirmed metastatic Renal Cell Cancer of clear-cell subtype with a resectable asymptomatic in situ primary.
  • metastatic RCC (mRCC): metastases are not completely resectable at the time of surgery or during an additional intervention. Multiple lesions at one site will make the patient not eligible for complete resection.
  • histology "clear-cell" subtype: If the diagnosis is not established patients need to undergo a transcutaneous tru-cut needle biopsy of the primary tumor.
  • resectable tumor: primary tumor must be resectable and resectability should not be doubtful at entry. Patients with distant metastases and bulky locoregional lymph node metastases larger than the primary tumor can be included if resectability of the lymph nodes is surgically feasible.
  • asymptomatic primary: is defined as the absence of symptoms which can be exclusively assigned to the primary tumor such as flank pain and/or gross hematuria necessitating blood transfusion. As para-neoplastic symptoms cannot be assigned to the primary tumor alone in metastatic disease, they are not included in this definition.
  • patients who will receive Sunitinib (Sutent®) as background therapy.
  • measurable disease according to RECIST 1.1 criteria.
  • prior therapies:
    • prior systemic therapy for metastatic RCC is not allowed
    • prior local radiotherapy for bone lesions is allowed
  • concomitant medications:
    • investigational or systemic therapy for metastatic RCC must not be used during the period of protocol treatment.
    • no systemic corticosteroid and/ or other immunosuppressive systemic therapies
  • age ≥ 18 years.
  • life expectancy > 3 months.
  • WHO performance status 0 or 1.
  • adequate bone marrow function (Leucocytes > 3.0 x 109/l, platelets >100 x 109/l, hemoglobin > 6.0 mmol/l or > 10.0 g/dL.)
  • prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN).
  • partial thromboplastin time (PTT) ≤ 1.2 x ULN.
  • adequate hepatic function (bilirubin ≤ 1.5 x ULN, SGPT/ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver lesions).
  • serum calcium < 10.0 mg/dL.
  • adequate renal function: calculated or measured  clearance creatinine >30 ml/min.
  • clinically normal cardiac function based on the institutional lower limit of normal  LVEF assessed by MUGA or ECHO and normal 12 lead ECG.
  • patients with any history of malignancies who are disease-free for more than 5 years are eligible.
  • women must be post-menopausal with a total cessation of menses of >1 year, or if of childbearing potential must not be pregnant (negative serum pregnancy test at entry) or lactating; and must agree to use effective contraceptive methods (with a documented failure rate < 1%
  • absence of any psychological, familial, sociological or geographical condition potentially hampering  compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
  • before patient randomization, written informed consent must be given
Exclusion criteria  :

Patients:

  • for whom complete surgical remission can be achieved by removing metastatic sites at nephrectomy or during an additional intervention.
  • with symptomatic primary necessitating nephrectomy. 
  • with previous partial or total nephrectomy.
  • with unresectable bulky locoregional lymph node metastases larger than the primary tumor.
  • with only bone metastases.
  • having more than 3 of the following surgical risk factors will not be eligible:
    • serum albumin CTCAE v4.0 grade 2 or worse
    • serum LDH > 1.5 x UNL
    • liver metastases
    • symptoms at presentation due to mestastases
    • retroperitoneal lymph node involvement
    • supra diaphragmatic lymph node involvement
    • clinical stage T3 or T4
  • with serious cardiac illness (myocardial infarction and/or (un)treatable angina pectoris not responding to treatment) within the past 12 months.
  • uncontrolled high blood pressure (BP) defined as BP ≥ 150/100 mm Hg despite optimal medical therapy.
  • clinical  signs of CNS involvement.
  • current pulmonary disease.
  • patients with active or uncontrolled infections or with serious illnesses, malabsorption syndrome or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV and/or cirrhosis.
  • history, within the past five years, of malignancies other than renal cell carcinoma (except: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score ≤ 6 and postoperative PSA < 0.5 ng/ml).
 
Treatment/therapy  :

immediate versus deferred nephrectomy

ARM  :
ARM description status
date
A Immediate Nephrectomy open 01-11-2010
B Deferred Nephrectomy open 01-11-2010
 
Status nation wide  :
remarks status date
Protocol versie 1.1 incl. administrative amendment 1 open 01-11-2010
Protocol versie 1.1 incl. administrative amendment 1 in preparation 10-09-2009
Protocol versie 1.1 incl. administrative amendment 1 in progress 10-09-2009
 
Amendement  :
description version date
administrative 1 10-09-2009
 
Trial co-ordinator(s)  :
A Bex,   Antoni van Leeuwenhoek Ziekenhuis   AMSTERDAM
 
CKTO-approved  : yes (09-11-2010)
 
Support  :
activity by tel. location
Local datamanagement Trialbureau IKNL - locatie Maastricht 043 325 40 59 Maastricht
Local datamanagement Trialbureau IKNL-locatie Nijmegen 024 361 68 37 Nijmegen
Central datamanagement European organisation for research and treatment of cancer, Belgie 0032 2 7741611 Rest of the World
Local datamanagement Trialbureau IKNL-locatie Utrecht 030 250 62 86 Utrecht
 
Patients  : 11 total included via datamanagement IKC's
 
Links  : EORTC

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