The STAT-ROC feasibility study
| ISRCTN | ISRCTN98060456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98060456 |
| EudraCT/CTIS number | 2014-001318-24 |
| Secondary identifying numbers | 17147 |
- Submission date
- 08/01/2015
- Registration date
- 08/01/2015
- Last edited
- 06/02/2020
- 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
Not provided at time of registration
Contact information
Dr Leo Alexandre
Scientific
Scientific
University of East Anglia
Earlham Road
Norwich
NR4 7TJ
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A feasibility study of adjuvant STATin therapy in the prevention of postoperative Recurrence of Oesophageal adenoCarcinoma (The STATROC feasibility study) |
| Study acronym | STATROC |
| Study hypothesis | This study is a single-centre, blinded, parallel group, randomised controlled trial to determine the feasibility of investigating adjuvant statin therapy in the prevention of post-operative recurrence of oesophageal and gastro-oesophageal adenocarcinoma in a future phase III RCT. Patients who have undergone potentially curative surgery will be randomised to receive either simvastatin 40mg nocte or placebo on discharge from hospital for one year. Participants will be assessed at screening, baseline and at months 3, 6, 9 and 12. Assessments will include measurements of recruitment and retention, absorption, adherence, safety, quality of life, disease-free and overall survival and generalisability. |
| Ethics approval(s) | 14/SC/0247; First MREC approval date 01/07/2014 |
| Condition | Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus |
| Intervention | Placebo, Microencapsulated lactose tablets, oral administration nocte; Simvastatin 40mg, Microencapsulated generic simvastatin film coated tablets, 40mg, oral administration nocte; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Simvastatin |
| Primary outcome measure | Absorption; Timepoint(s): LDL cholesterol at 3, 6, 9 and 12 months from discharge from hospital following surgery |
| Secondary outcome measures | 1. Adherence; Timepoint(s): Pill counts at 3, 6, 9 and 12 months from discharge from hospital following surgery 2. Generalisability; Timepoint(s): Screening and Baseline visits; 3. Overall and disease-free survival; Timepoint(s): Up to one year post-discharge following surgery 4. Quality of life; Timepoint(s): Baseline, 3, 6, 9 and 12 months post-discharge following surgery. 5. Recruitment; Timepoint(s): Measured between 21/10/14 and 31/10/15 6. Retention; Timepoint(s): Measured between randomisation of first participant and date of end of follow-up (latest 31/10/16) 7. Safety; Timepoint(s): Adverse events will be continuously recorded from the date of first trial medication administration |
| Overall study start date | 21/10/2014 |
| Overall study end date | 31/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 36; UK Sample Size: 36; Description: As this is a feasibility study a formal sample size calculation is not required. |
| Total final enrolment | 32 |
| Participant inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the trial 2. Male or female, aged 18 years or above 3. Diagnosed with oesophageal adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction [Siewert 1 or 2 lesions]) confirmed with both endoscopy and histology 4. Due to undergo potentially curative surgery with either an oesophagectomy, oesophagogastrectomy or extended total gastrectomy and survive to discharge from hospital following their operation |
| Participant exclusion criteria | 1. Currently prescribed a statin as part of their routine clinical care 2. Due to be prescribed a statin as part of their routine clinical care. Applicable to a participant who has agreed to statin therapy as recommended by their general practitioner (GP) for the primary or secondary prevention of cardiovascular disease. NB: patients who qualify for a statin but who choose not to be prescribed one for primary or secondary prevention of cardiovascular disease are still potentially eligible for this study 3. Hypersensitivity to simvastatin 4. Active liver disease or unexplained persistent elevations of serum transaminases (> 3x uppler limit of normal [ULN]) 5. Severe renal insufficiency (estimated glomerular filtration rate [eGFR] less than 30 mL/minute/1.73 m2). 6. Creatine kinase (CK) > 5x ULN 7. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 8. Concomitant drug prescription of potent CYP3A4 inhibitors planned for greater than 1 month during the study period (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, HIV protease inhibitors [e.g. nelfinavir], erythromycin, clarithromycin, telithromycin and nefazodone) 9. Concomitant drug prescription planned for greater than 1 month during the study period of amiodarone, verapamil, diltiazem, amlodipine, ciclosporin, danazol or gemfibrozil 10. Acute porphyria |
| Recruitment start date | 21/10/2014 |
| Recruitment end date | 31/10/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of East Anglia
Earlham Road
Norwich
NR4 7TJ
United Kingdom
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Norfolk and Norwich University Hospital NHS Trust
Hospital/treatment centre
Hospital/treatment centre
Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom
"ROR" |
https://ror.org/01wspv808 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2017 | Yes | No | |
| Results article | results | 01/02/2020 | 06/02/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/02/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
14/11/2017: Publication reference added.
