The STAT-ROC feasibility study

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus; Cancer

• Registration Number: ISRCTN98060456
• Lead Sponsor: orfolk and Norwich University Hospital NHS Trust

Brief Summary

2017 results in: http://gut.bmj.com/content/66/Suppl_2/A181.2# 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32011825 (added 06/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-08
• Study Completion: 2015-10-31
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absorption; Timepoint(s): LDL cholesterol at 3, 6, 9 and 12 months from discharge from hospital following surgery

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adherence; Timepoint(s): Pill counts at 3, 6, 9 and 12 months from discharge from hospital following surgery<br> 2. Generalisability; Timepoint(s): Screening and Baseline visits;<br> 3. Overall and disease-free survival; Timepoint(s): Up to one year post-discharge following surgery<br> 4. Quality of life; Timepoint(s): Baseline, 3, 6, 9 and 12 months post-discharge following surgery.<br> 5. Recruitment; Timepoint(s): Measured between 21/10/14 and 31/10/15<br> 6. Retention; Timepoint(s): Measured between randomisation of first participant and date of end of follow-up (latest 31/10/16)<br> 7. Safety; Timepoint(s): Adverse events will be continuously recorded from the date of first trial medication administration<br>