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Trial record 1 of 1 for:    surtime | Renal Cell Carcinoma
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Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer (SURTIME)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01099423
First Posted: April 7, 2010
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wales Cancer Trials Unit
Canadian Urologic Oncology Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  Purpose

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether undergoing immediate surgery or surgery after sunitinib malate is more effective in treating patients with metastatic kidney cancer.

PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it works compared with surgery after sunitinib malate in treating patients with metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer Procedure: timing of surgery Genetic: gene expression analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: therapeutic conventional surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Overall progression-free survival

Secondary Outcome Measures:
  • Overall survival
  • Morbidity
  • Overall response to treatment in the deferred nephrectomy arm including the proportion of patients who become unresectable
  • Effect of nephrectomy on early progression in both arms

Enrollment: 99
Actual Study Start Date: April 2010
Estimated Study Completion Date: May 2017
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate nephrectomy
Surgery followed by Sunitinib
Genetic: gene expression analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: therapeutic conventional surgery
Experimental: Deferred nephrectomy
Sunitinib (3 cycles) followed by surgery followed by Sunitinib
Procedure: timing of surgery Genetic: gene expression analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

  • 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.
  • To identify potential response criteria based on histopathology and molecular research on tumor tissue.

OUTLINE: This is a multicenter study. Patients are stratified according to WHO performance status (0 vs 1), number of metastatic sites (1 vs 2 or more), and institution. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (immediate nephrectomy): Patients undergo cytoreductive nephrectomy. Beginning 4 weeks after surgery, patients receive oral sunitinib malate once daily on days 1-28. Treatment with sunitinib malate repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (deferred nephrectomy): Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. About 1 day after completion of sunitinib malate, patients undergo cytoreductive nephrectomy. Patients then receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo tumor tissue collection at baseline and at time of surgery to assess possible differences in gene expression. Patients also undergo blood sample collection periodically to evaluate the potential impact of serum proteins on the clinical outcome. Samples are then stored for future studies.

After completion of study treatment, patients are followed periodically.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed renal cell cancer (RCC)

    • Clear-cell subtype with a resectable asymptomatic in situ primary

      • 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 NOTE: *Para-neoplastic symptoms cannot be assigned to the primary tumor alone in metastatic disease, they are not included in this definition.
      • No symptomatic primary tumor necessitating nephrectomy
  • Resectable primary tumor

    • Bulky locoregional lymph node metastases larger than the primary tumor allowed provided resectability of the lymph nodes is surgically feasible
  • Metastatic RCC

    • Distant metastases are not completely resectable at the time of surgery or during an additional intervention
    • No multiple distant lesions at one site
    • No bone-only metastases
  • Measurable disease, both primary and metastatic, according to RECIST 1.1 criteria
  • Planning to receive sunitinib malate as background therapy
  • Patients with > 3 of the following surgical risk factors are not eligible:

    • Serum albumin CTCAE v 4.0 grade 2 or worse
    • Serum LDH > 1.5 times upper limit of normal
    • Liver metastases
    • Symptoms at presentation due to metastases
    • Retroperitoneal lymph node involvement
    • Supra-diaphragmatic lymph node involvement
    • Clinical stage T3 or T4 disease
  • No clinical signs of CNS involvement

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • WHO performance status 0-1
  • Life expectancy > 3 months
  • WBC > 3.0 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Hemoglobin > 10.0 g/dL
  • PT/PTT or INR ≤ 1.2 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver lesions)
  • Serum calcium < 10.0 mg/dL
  • Calculated or measured creatinine clearance > 30 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception 2 weeks before and during study treatment
  • LVEF normal by MUGA scan or ECHO
  • 12-lead ECG normal
  • No serious cardiac illness (myocardial infarction and/or treatable or untreatable angina pectoris not responding to treatment) within the past 12 months
  • No uncontrolled, high BP (≥ 150/100 mm Hg) despite optimal medical therapy
  • No current pulmonary disease
  • No active or uncontrolled infections, serious illnesses, malabsorption syndrome, or medical conditions, including patients with a history of chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis
  • No malignancies within the past 5 years except renal cell carcinoma, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score ≤ 6 and postoperative PSA < 0.5 ng/mL, or patients with any history of malignancies who are disease-free for more than 5 years
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

  • Prior local radiotherapy for bone lesions allowed
  • No prior systemic therapy for metastatic RCC
  • No prior partial or total nephrectomy
  • No concurrent systemic corticosteroid and/or other immunosuppressive systemic therapies
  • No concurrent radiotherapy, except palliative radiotherapy
  • No concurrent participation in another clinical trial testing treatments for any disease including renal cell carcinoma
  • No other concurrent investigational or systemic therapy for metastatic RCC
  Contacts and Locations
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): NCT01099423


Locations
Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium
Cliniques Universitaires St. Luc
Brussels, Belgium
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Gent
Gent, Belgium
Virga Jesse Hospital
Hasselt, Belgium
AZ Groeninghe - Campus Loofstraat
Kortrijk, Belgium
AZ Damiaan - Campus Sint-Jozef
Oostende, Belgium
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Canada, Quebec
CHUM - Pavillon Saint-Luc
Montreal,, Quebec, Canada
Canada
Montreal General Hospital
Montreal, Canada
The Ottawa Hospital, The Integrated Cancer Program- General Campus
Ottawa, Canada
University Health Network - Oci / Princess Margaret Hospital
Toronto, Canada
Diamond Health Care Centre
Vancouver, Canada
Italy
San Camillo Forlanini Hospitals
Roma, Italy
Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, Netherlands
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Universitair Medisch Centrum - Academisch Ziekenhuis
Utrecht, Netherlands
United Kingdom
Royal United Hospital
Bath, United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, United Kingdom
St. James'S University Hospital
Leeds, United Kingdom
Barts and The London NHS Trust - St. Bartholomew'S Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, United Kingdom
Christie NHS Foundation Trust
Manchester, United Kingdom
Singelton Hospital
Swansea, United Kingdom
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Wales Cancer Trials Unit
Canadian Urologic Oncology Group
Institute of Cancer Research, United Kingdom
Investigators
Study Chair: Axel Bex The Netherlands Cancer Institute
Study Chair: John B.A.G. Haanen The Netherlands Cancer Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01099423     History of Changes
Other Study ID Numbers: EORTC-30073
EU-21022
PFIZER-EORTC-30073
First Submitted: April 6, 2010
First Posted: April 7, 2010
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
clear cell renal cell carcinoma
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Carcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urologic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors