Phase
Condition
Kidney Cancer
Urothelial Cancer
Urothelial Tract Cancer
Treatment
N/AClinical Study ID
Ages 18-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
Onze Lieve Vrouw Ziekenhuis
Aalst,
BelgiumSite Not Available
Cliniques Universitaires St. Luc
Brussels,
BelgiumSite Not Available
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels,
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent,
BelgiumSite Not Available
Virga Jesse Hospital
Hasselt,
BelgiumSite Not Available
AZ Groeninghe - Campus Loofstraat
Kortrijk,
BelgiumSite Not Available
AZ Damiaan - Campus Sint-Jozef
Oostende,
BelgiumSite Not Available
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
CanadaSite Not Available
CHUM - Pavillon Saint-Luc
Montreal,, Quebec
CanadaSite Not Available
Montreal General Hospital
Montreal,
CanadaSite Not Available
The Ottawa Hospital, The Integrated Cancer Program- General Campus
Ottawa,
CanadaSite Not Available
University Health Network - Oci / Princess Margaret Hospital
Toronto,
CanadaSite Not Available
Diamond Health Care Centre
Vancouver,
CanadaSite Not Available
San Camillo Forlanini Hospitals
Roma,
ItalySite Not Available
Jeroen Bosch Ziekenhuis
's-Hertogenbosch,
NetherlandsSite Not Available
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam,
NetherlandsSite Not Available
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam,
NetherlandsSite Not Available
Vrije Universiteit Medisch Centrum
Amsterdam,
NetherlandsSite Not Available
University Medical Center Groningen
Groningen,
NetherlandsSite Not Available
Academisch Ziekenhuis Maastricht
Maastricht,
NetherlandsSite Not Available
Radboud University Nijmegen Medical Centre
Nijmegen,
NetherlandsSite Not Available
Universitair Medisch Centrum - Academisch Ziekenhuis
Utrecht,
NetherlandsSite Not Available
Royal United Hospital
Bath,
United KingdomSite Not Available
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol,
United KingdomSite Not Available
St. James'S University Hospital
Leeds,
United KingdomSite Not Available
Barts and The London NHS Trust - St. Bartholomew'S Hospital
London,
United KingdomSite Not Available
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London,
United KingdomSite Not Available
Christie NHS Foundation Trust
Manchester,
United KingdomSite Not Available
Singelton Hospital
Swansea,
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.