Condition category
Cancer
Date applied
31/05/2007
Date assigned
30/08/2007
Last edited
18/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Tim Eisen

ORCID ID

Contact details

Oncology Centre
Box 193
Addenbrooke's Hospital
Robinsons Way
Cambridge
CB2 2RE
United Kingdom
-
tgqe2@cam.ac.uk

Additional identifiers

EudraCT number

2006-006079-19

ClinicalTrials.gov number

NCT00492258

Protocol/serial number

RE05

Study information

Scientific title

SORCE: 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

Acronym

SORCE

Study hypothesis

SORCE aims to answer two questions:
1. Whether at least one year of treatment with sorafenib increases Disease-Free Survival (DFS) compared with placebo.
2. Whether three years of treatment with sorafenib increases DFS compared to one year of treatment.

Ethics approval

South East Research Ethics Committee, South East Coast Health Authority, 02/04/2007, ref: 07/MRE01/10

Study design

Randomised double-blind placebo-controlled multi-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Primary renal cell carcinoma

Intervention

Patients will be randomly assigned to one of the following:
Arm A: 3 years of placebo
Arm B: 1 year of sorafenib followed by 2 years of placebo
Arm C: 3 years of sorafenib

Sorafenib will be given at 400 mg po (per oral) bd (twice daily) doses. Patients with disease progression who are in Arm A or B within 3 years of start of treatment whilst on placebo will be offered compassionate use of sorafenib at the standard dose of 400 mg po bd until further progression/toxicity. This is referred to throughout the protocol as open-label sorafenib.

Intervention type

Drug

Phase

Phase III

Drug names

Sorafenib

Primary outcome measures

Disease Free Survival (DFS) (i.e. time from randomisation to first evidence of local recurrence or distant metastases or death from RCC)

Secondary outcome measures

1. RCC-specific survival time (i.e. time to death from RCC)
2. Overall Survival (OS)
3. Cost effectiveness
4. Toxicity
5. Biological characteristics of resected primary RCC:
5.1. von Hippel Lindau (VHL) protein
5.2. Vascular Endothelial Growth Factor Receptor-2 (VEGFR2)
5.3. Fibroblast Growth Factor 2 (FGF2)
5.4. B-Raf
5.5. MAPK ERK kinase (MEK)
5.6. Extracellular signal-Regulated Kinase (ERK)
6. Corroboration of Leibovich Prognostic Score (9 years after first patient entry)

Overall trial start date

01/06/2007

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven Renal Cell Carcinoma (RCC)
2. No evidence of residual macroscopic disease on post-operative Computed Tomography (CT) scan after resection of RCC. Patients with clear cell or non-clear cell tumours are eligible
3. Patients with 'Intermediate' or 'High' risk per the Leibovich score 3 to 11
4. Subjects must be >18 years of age
5. Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment phase of the study and for 9 months afterwards. Women who wish to breastfeed are not eligible for the study
6. Adequate bone marrow function (White Blood Cells > 3.4x109/l, platelets > 99x109/l), renal function (creatinine < 2.5 x upper limit of normal and hepatic function (liver function test [LFT] < 1.5 x upper limit of normal) within 14 days prior to randomisation
7. Patients should have had surgery at least 4 weeks but no more than 3 months prior to treatment start date
8. Serum amylase < 1.5 x upper limit of normal
9. ProThrombin (PT) or International Normalized Ratio (INR) and ProThrombin Time (PTT) < 1.5 x upper limit of normal
10. World Health Organization Performance Status 0 or 1
11. Written Informed Consent obtained

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1656

Participant exclusion criteria

1. Prior anti-cancer treatment for RCC other than nephrectomy
2. 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 > NYHA Class II
3. Active clinically serious bacterial or fungal infections
4. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
5. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate birth control
6. Prior malignancy (except for cervical carcinoma in situ or adequately treated basal cell carcinoma)
7. Concomitant medications which have adverse interactions with sorafenib: rifampin, grapefruit juice, ritonavir, ketoconazole, itraconazole and St John's Wort
8. Patients with uncontrolled hypertension

Recruitment start date

01/06/2007

Recruitment end date

01/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2RE
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

MRC Centre London
Second Floor
Stephenson House
158-160 North Gower Street
London
NW1 2ND
United Kingdom
-
iv@centre-london.mrc.ac.uk

Sponsor type

Government

Website

http://www.ctu.mrc.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Cancer Research UK, Clinical Trials Advisory and Awards Committee (CTAAC)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Bayer AG (educational grant plus free Sorafenib/matched placebo for all patients) (International)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes