Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000048280
Ethics application status
Approved
Date submitted
7/11/2008
Date registered
21/01/2009
Date last updated
13/10/2020
Date data sharing statement initially provided
13/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase III study comparing Sorafenib with placebo in patients who have had kidney cancer removed (SORCE)
Scientific title
A phase III randomised double-blind study comparing Sorafenib with placebo in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse.
Secondary ID [1] 282450 0
NCT00492258
Secondary ID [2] 282451 0
ISRCTN38934710
Universal Trial Number (UTN)
Trial acronym
SORCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal cancer 3948 0
Condition category
Condition code
Cancer 4143 4143 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1 and group 2 will self administer 400 mg of sorafenib (2 x 200 mg tablets) and Intervention group 3 will self-administer matching placebo tablets once per day for 21 days. At 21 days the dose will be increased to 400 mg (2 x 200mg tablets) or matching placebo twice per day if the patient has not experienced greater than Grade I skin toxicity or greater than Grade II of any other toxicity. Dose escalation may be deferred until at least the planned 6 week visit if toxicities do occur. After the first 21 days Intervention group 1 and group 2 will receive sorafenib at 400mg oral dose (2 x 200mg tablets) twice daily until the end of the first year, followed by Placebo (2 x oral sugar pills twice daily for 2 years). Intervention group 2 will receive sorafenib at 400mg oral dose (2 x 200mg tablets) twice daily until the completion of the three years. The tablets should be swallowed whole with a glass of water. The tablets should be taken without food (at least 1 hour before or 2 hours after eating) or with a moderate fat meal. Twice daily doses should be separated by approximately 12 hours.
Intervention code [1] 3742 0
Treatment: Drugs
Comparator / control treatment
The comparator/control gorup will receive placebo (2 x oral sugar pills twice daily for 3 years).
Control group
Placebo

Outcomes
Primary outcome [1] 5042 0
Disease-free survival, measured by 6-monthly computer tomography (CT) of chest, abomen and pelvis, with 6-monthly chest x-rays in-between.
Timepoint [1] 5042 0
Baseline, 3 weeks, 6 weeks and 3 months post-randomisation, then 3-monthly until 3 years post-randomisation. 6-monthly chest x-rays only between 3 and 6 years post-randomisation. Yearly chest x-rays only following first 5 years.
Secondary outcome [1] 8708 0
Renal cell carcinoma (RCC)-specific survival time
Timepoint [1] 8708 0
Baseline, 3 weeks, 6 weeks and 3 months post-randomisation, then 3-monthly until 5 years post-randomisation. Yearly following first 5 years.
Secondary outcome [2] 8709 0
overall survival
Timepoint [2] 8709 0
Clinical examination follow-up of patients at 3 weeks, 6 weeks and 3 months post-randomisation, then 3-monthly until 3 years post-randomisation. 6-monthly between 3 and 6 years post-randomisation. Yearly following first 5 years.
Secondary outcome [3] 8711 0
Toxicities will be measured using Cancer Toxicity Criteria for Adverse Events (CTCAE) version 3.0.
Timepoint [3] 8711 0
Baseline, 3 weeks, 6 weeks and 3 months post-randomisation, then 3-monthly until 5 years post-randomisation. Yearly following first 5 years.
Secondary outcome [4] 8712 0
biological characteristics of resected primary RCC (ie the Von Hippel Lindau (VHL) gene, the vascular endothelial growth factor receptor 2 (VEGFR2) gene, fibroblast growth factor 2 (FGF2), B-RAF, MEK, ERK).
Timepoint [4] 8712 0
Measured from tissue collected at time of surgery and blood collected at time of randomisation.
Secondary outcome [5] 8713 0
Leibovich Calculated Score for risk of relapse in renal cell carcinoma
Timepoint [5] 8713 0
At time of surgery.

Eligibility
Key inclusion criteria
Inclusion criteria: Histologically proven renal cell carcinoma. No evidence of residual macroscopic disease on post-operative Computerised Tomography (CT) scan after resection of renal cell carcinoma. Patients with clear cell or non-clear cell tumours are eligible. Patients with "intermediate" or "high" risk per the Leibovich score 3 to 11. Subjects must be >18 years in age. Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment phase of hte study and for 9 months afterwards. Women who wish to breast feed are not eligible for the study. Adequate bone marrow function (White Blood Cell (WBC) > 3.4 x 109/L, platelets > 99 x 109/L) renal function (creatinine < 2.5 x the Upper Limit of Normal (ULN)) and hepatic function (Liver Function Test (LFT) < 1.5 x ULN) within 14 days prior to randomisation. Patients should have had surgery at least 4 weeks but no more than 3 months (91d) prior to treatment start date. Serum amylase < 1.5 x ULN Prothrombin or International Normalised Ratio (INR) and prothrombin time < 1.5 x ULN World Health Organisation (WHO) performance status 0 or 1. Written informed consent obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior anti-cancer treatment for renal cell carcinoma other than nephrectomy Cardiac arrhythmias requiring anti-arrhythmics (beta blockers and digoxin are allowed), symptomatic coronary artery disease or ischaemia, myocardial infarction within the last 6 months, congestive cardiac failure > (New York Heart Association (NYHA) class II. Active clinically serious bacterial or fungal infections. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. Pregnant or breast-feeding patients. Prior malignancy (except for cervical carcinoma in situ or adequately treated basal cell carcinoma). Concomitant medications which have adverse interactions with sorafenib: rifampin, grapefruit juice, ritonavir, ketoconazole, itraconazole and St John's Wort. Patients with uncontrolled hypertension.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2009
Actual
1/06/2007
Date of last participant enrolment
Anticipated
1/06/2012
Actual
12/04/2013
Date of last data collection
Anticipated
Actual
10/03/2020
Sample size
Target
1656
Accrual to date
Final
1711
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,TAS
Recruitment outside Australia
Country [1] 1360 0
Netherlands
State/province [1] 1360 0
Country [2] 1361 0
United Kingdom
State/province [2] 1361 0
Country [3] 1362 0
Denmark
State/province [3] 1362 0
Country [4] 1363 0
Spain
State/province [4] 1363 0
Country [5] 1364 0
Belgium
State/province [5] 1364 0
Country [6] 1365 0
France
State/province [6] 1365 0

Funding & Sponsors
Funding source category [1] 4132 0
Government body
Name [1] 4132 0
Clinical Trials Advisory and Awards Committee (CTAAC): Cancer Research UK
Country [1] 4132 0
United Kingdom
Funding source category [2] 4261 0
Commercial sector/Industry
Name [2] 4261 0
Bayer AG
Country [2] 4261 0
Germany
Funding source category [3] 269998 0
Other Collaborative groups
Name [3] 269998 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)
Country [3] 269998 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Medical Research Council
Address
222 Euston Road
London
NW1 2DA
Country
United Kingdom
Secondary sponsor category [1] 3717 0
University
Name [1] 3717 0
University of Sydney
Address [1] 3717 0
NHMRC Clinical Trials Centre
Level 6, Medical Foundations Building, 92-94 Parramatta Road Camperdown NSW 2050
Country [1] 3717 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271958 0
Sydney Local Health District Ethics Review Committee (RPAH zone)
Ethics committee address [1] 271958 0
Ethics committee country [1] 271958 0
Australia
Date submitted for ethics approval [1] 271958 0
Approval date [1] 271958 0
05/11/2008
Ethics approval number [1] 271958 0
AU RED Reference Number: 08/CIC/26
Cancer Institute NSW Reference Number: 2008C/08/060
Ethics committee name [2] 294475 0
ACT Health Human Research Ethics Committee
Ethics committee address [2] 294475 0
Ethics committee country [2] 294475 0
Australia
Date submitted for ethics approval [2] 294475 0
Approval date [2] 294475 0
11/05/2009
Ethics approval number [2] 294475 0
Ethics committee name [3] 294476 0
The Alfred Hospital Ethics Committee
Ethics committee address [3] 294476 0
Ethics committee country [3] 294476 0
Australia
Date submitted for ethics approval [3] 294476 0
Approval date [3] 294476 0
21/05/2009
Ethics approval number [3] 294476 0
Ethics committee name [4] 294477 0
Eastern Health Human Research Ehics Committee
Ethics committee address [4] 294477 0
Ethics committee country [4] 294477 0
Australia
Date submitted for ethics approval [4] 294477 0
Approval date [4] 294477 0
01/07/2010
Ethics approval number [4] 294477 0
Ethics committee name [5] 294478 0
Austin Health Human Research Ethics Committee
Ethics committee address [5] 294478 0
Ethics committee country [5] 294478 0
Australia
Date submitted for ethics approval [5] 294478 0
Approval date [5] 294478 0
17/10/2007
Ethics approval number [5] 294478 0
Ethics committee name [6] 294479 0
Bellberry Limited Human Research Ethics Committee
Ethics committee address [6] 294479 0
Ethics committee country [6] 294479 0
Australia
Date submitted for ethics approval [6] 294479 0
Approval date [6] 294479 0
30/11/2010
Ethics approval number [6] 294479 0
Ethics committee name [7] 294480 0
The Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [7] 294480 0
Ethics committee country [7] 294480 0
Australia
Date submitted for ethics approval [7] 294480 0
Approval date [7] 294480 0
29/06/2009
Ethics approval number [7] 294480 0
Ethics committee name [8] 294481 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [8] 294481 0
Ethics committee country [8] 294481 0
Date submitted for ethics approval [8] 294481 0
Approval date [8] 294481 0
05/10/2007
Ethics approval number [8] 294481 0
Ethics committee name [9] 294482 0
The Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [9] 294482 0
Ethics committee country [9] 294482 0
Australia
Date submitted for ethics approval [9] 294482 0
Approval date [9] 294482 0
05/11/2009
Ethics approval number [9] 294482 0
Ethics committee name [10] 294483 0
Sir Charles Giardner Group Human Research Ethics Committee
Ethics committee address [10] 294483 0
Ethics committee country [10] 294483 0
Australia
Date submitted for ethics approval [10] 294483 0
Approval date [10] 294483 0
14/07/2009
Ethics approval number [10] 294483 0
Ethics committee name [11] 294484 0
South Metropolitam Area Health Service Human Research Ethics Committee
Ethics committee address [11] 294484 0
Ethics committee country [11] 294484 0
Australia
Date submitted for ethics approval [11] 294484 0
Approval date [11] 294484 0
03/06/2009
Ethics approval number [11] 294484 0
Ethics committee name [12] 294485 0
Human Research Ethics Committee of Tasmania
Ethics committee address [12] 294485 0
Ethics committee country [12] 294485 0
Australia
Date submitted for ethics approval [12] 294485 0
Approval date [12] 294485 0
13/08/2009
Ethics approval number [12] 294485 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29107 0
Prof Ian Davis
Address 29107 0
Eastern Health Clinical School
Faculty of Medicine, Nursing and Health Sciences
Level 2, 5 Arnold St
Box Hill
Vic 3128
Australia
Country 29107 0
Australia
Phone 29107 0
+61 2 9562 5000
Fax 29107 0
Email 29107 0
sorce@ctc.usyd.edu.au
Contact person for public queries
Name 12264 0
SORCE Trial Coordinator
Address 12264 0
NHMRC Clinical Trials Centre
The Lifehouse Building
Level 6
119 -143 Missenden Road
Camperdown NSW 2050
Country 12264 0
Australia
Phone 12264 0
(02) 9562 5000
Fax 12264 0
(02) 9562 5094
Email 12264 0
sorce@ctc.usyd.edu.au
Contact person for scientific queries
Name 3192 0
SORCE Trial Coordinator
Address 3192 0
NHMRC Clinical Trials Centre
The Lifehouse Building
Level 6
119 -143 Missenden Road
Camperdown NSW 2050
Country 3192 0
Australia
Phone 3192 0
(02) 9562 5000
Fax 3192 0
(02) 9562 5094
Email 3192 0
sorce@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
to be confirmed with the sponsor


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.