Condition category
Cancer
Date applied
08/01/2015
Date assigned
08/01/2015
Last edited
08/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Leo Alexandre

ORCID ID

Contact details

University of East Anglia
Earlham Road
Norwich
NR4 7TJ
United Kingdom

Additional identifiers

EudraCT number

2014-001318-24

ClinicalTrials.gov number

Protocol/serial number

17147

Study information

Scientific title

A feasibility study of adjuvant STATin therapy in the prevention of postoperative Recurrence of Oesophageal adenoCarcinoma (The STATROC feasibility 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

14/SC/0247; First MREC approval date 01/07/2014

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Other

Phase

Drug names

Primary outcome measures

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 trial start date

21/10/2014

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

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.

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

United Kingdom

Trial participating centre

University of East Anglia
Earlham Road
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospital NHS Trust

Sponsor details

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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