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
| ISRCTN | ISRCTN38934710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38934710 |
| ClinicalTrials.gov (NCT) | NCT00492258 |
| Clinical Trials Information System (CTIS) | 2006-006079-19 |
| Protocol serial number | ACTRN12609000048280; RE05 |
| Sponsor | Medical Research Council (UK) |
| Funders | Medical Research Council (UK), Cancer Research UK, Clinical Trials Advisory and Awards Committee (CTAAC), Bayer (educational grant plus free Sorafenib/matched placebo for all patients) (International) |
- Submission date
- 31/05/2007
- Registration date
- 30/08/2007
- Last edited
- 08/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Tim Eisen
Scientific
Scientific
Oncology Centre
Box 193
Addenbrooke's Hospital
Robinsons Way
Cambridge
CB2 2RE
United Kingdom
| tgqe2@cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled multi-centre study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | SORCE |
| Study objectives | 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(s) | South East Research Ethics Committee, South East Coast Health Authority, 02/04/2007, ref: 07/MRE01/10 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Sorafenib |
| Primary outcome measure(s) |
Disease Free Survival (DFS) (i.e. time from randomisation to first evidence of local recurrence or distant metastases or death from RCC) |
| Key secondary outcome measure(s) |
1. RCC-specific survival time (i.e. time to death from RCC) |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1656 |
| Total final enrolment | 1711 |
| Key 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 |
| Key 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 breastfeeding 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 |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2RE
United Kingdom
CB2 2RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/12/2012 | Yes | No | |
| Results article | results | 01/02/2018 | Yes | No | |
| Results article | 01/12/2020 | 08/04/2021 | Yes | No | |
| Abstract results | baseline information | 01/02/2014 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
08/04/2021: Publication reference and total final enrolment added.
16/12/2020: Cancer Research UK lay results summary link added to Results (plain English).
11/03/2019: Publication references added.
11/10/2017: No publications found, verifying study status with principal investigator.
