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RTL Advanced Study

RTL Advanced Study. An Analysis of Relative Telomere Length (RTL) during Chemotherapy in Patients Advanced Gastro-oesophageal Adenocarcinoma (Version 3, 23 rd October 2014). Study Organisation. Sponsored (Research Governance) - Greater Glasgow and Clyde Health Board (GGCHB

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RTL Advanced Study

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  1. RTL Advanced Study An Analysis of Relative Telomere Length (RTL) during Chemotherapy in Patients Advanced Gastro-oesophageal Adenocarcinoma (Version 3, 23rd October 2014)

  2. Study Organisation • Sponsored (Research Governance) - Greater Glasgow and Clyde Health Board (GGCHB • Coordinated by CR-UK Clinical Trials Unit in Glasgow • CR-UK CTU Glasgow are responsible for setting up, day-to-day running, analysis and presentation of results • Chief Investigator is Professor Jeff Evans, The Beatson West of Scotland Cancer Centre (BWoSCC)

  3. Study Team • CR-UK CTU Team • Chief Investigator: Professor Jeff Evans • Trial Statistician: Jim Paul • Project Management: Liz-Anne Lewsley • Clinical Trial Co-ordinator: Laura Douglas • Laboratory Contact: Jennifer Walker

  4. Study Summary • Multi-centre, open, non-randomised study. • Study recruitment: 330 patients. • Study population: patients with locally advanced or metastatic gastric, gastro-oesophageal junction or oesophageal carcinoma who are due to start chemotherapy with either the ECX/ECF or EOX/EOF regimens (patients randomised to the NCRN REAL-3 study to receive EOX + panitumumab will also be eligible). • Timelines: - Recruitment started (Glasgow) May 2010 - Planned accrual completion is December 2017

  5. Objectives & Endpoints Primary Objective • to analyse Relative Telomere Length (RTL) in blood samples taken from patients during chemotherapy for advanced gastro-oesophageal adenocarcinoma. This will allow us to determine if the baseline (pre-treatment) RTL correlates with tumour response i.e. to determine if the baseline RTL predicts tumours that are sensitive or resistant to chemotherapy. Secondary Objective • to analyse changes in markers associated with cellular senescence in blood samples taken from patients during chemotherapy for advanced gastro-oesophageal adenocarcinoma. These will include cathelicidin-related antimicrobial protein (CRAMP), EF-1a, stathmin, and chitinase 3-like protein 3. Tertiary (Exploratory) Objectives • to analyse changes in CK-18 in blood samples taken from patients during chemotherapy for advanced gastro-oesophageal adenocarcinoma as a marker of drug-induced cell death by apoptosis. • to analyse changes in senescence-associated micro-RNAs in blood samples taken from patients during chemotherapy for advanced gastro-oesophageal adenocarcinoma. • to analyse if any changes in RTL in blood samples taken from patients during chemotherapy for advanced gastro-oesophageal adenocarcinoma give an early indication of outcome (objective response, overall survival).

  6. Patient Registration Procedure for all sites • Check that patient has given written informed consent • Check that patient fulfils eligibility criteria • Complete Registration Form • PHONE or FAX registration details to the CRUK CTU Registration/Randomisation Service • Each patient registered will be allocated a unique trial number (3-digits)

  7. Registration/Randomisation Service CRUK CTU Glasgow registration/randomisation service: Tel: 0141 301 7215 Fax: 0141 301 7219* 08:30 –17:00 Mon–Thurs, 08.30-16.30 Friday (except public holidays) *Faxes received outside of office hours will be processed the next working day

  8. CR-UK CTU Glasgow - Main REC approval (Glasgow) - Overall Management Approval (Glasgow) - Site Initiation Calls/Meetings - Investigator File SITE - Staff Contact & Responsibilities Sheets - SSI / R&D (Management Approval) - Investigator CVs - Participating Site Agreement - GCP Certificates for PIs - PIS, Consent, GP Letter etc on local headed paper Site Set-up Initiation Call Notification by email SITE ACTIVATED

  9. Inclusion Criteria • Histologically or cytologically confirmed locally advanced or metastatic gastric, gastro-oesophageal junction, or oesophageal adenocarcinoma • Patients who are due to start chemotherapy with either the ECX/ECF (epirubicin, cisplatin and capecitabine/5-FU) or EOX/EOF (epirubicin, oxaliplatin and capecitabine/5-FU) regimens. Additionally, patients randomised in the NCRN REAL-3 study to receive EOX + panitumumab will also be eligible • Written informed consent • At least one lesion which is uni-dimensionally measureable by RECIST • Age >18 years • Able to comply with study protocol.

  10. Exclusion Criteria • Any evidence of any medical or psychiatric disorders that would be a contra-indication to venesection • Women who are pregnant or lactating • Patients who have had systemic anti-cancer therapy or radiotherapy within the previous 6 weeks • Life expectancy < 3 months

  11. Informed Consent Process-1 • Two original Consent Forms must be completed by a clinician (or deputy listed on Staff Contacts & Responsibilities Sheet) • Two originals signed and completed by the patient • Date must be on or prior to registration • Make one photocopy - Original to be filed in Investigator File - Original to be given to patient (+PIS) - Photocopy to be filed in hospital notes • Consent Form must not be sent to the CRUK coordinating trials office

  12. Informed ConsentProcess-2 • Errors noticed after consent - Add explanatory note/file note • New version of Patient Information Sheet must be provided to patients consented with previous version* - Give to all patients regardless of treatment stage either by post or during clinic visit • Patients who are still on study will be required to repeat the consent process using the updated form* • If not appropriate to re-consent patient (i.e. patient terminally ill) make a note on the re-consenting log * Due to the nature of this study, reconsent is unlikely to be an issue.

  13. Case Report Forms (CRFs) • Registration Form • Pre-Treatment Form • Treatment Form • Follow up Form

  14. CRF Completion • Black ball-point pen • Correction fluid etc. must not be used • Errors crossed out with a single stroke, correction inserted and change initialled and dated • An explanation can be written next to amendment if necessary • Date format: DD / MON / YYYY • Information on CRFs must be verifiable in source documents • Take photocopy of all completed CRFs • Original to CR-UK CTU Glasgow • CRF completion guidelines will be supplied

  15. Consent Withdrawal • This is when the patient specifically asks to withdraw their consent at any point in the study • Ensure that the level of consent withdrawal is clearly documented in the source data • If this occurs: • Document clearly in the patient notes that the patient has withdrawn consent, the level of consent withdrawal and the reason (if the patient has given any); • Complete the consent withdrawal notification form ; • Send the consent withdrawal notification form to the CR-UK CTU • No further follow-up should be collected on the patient from that point onwards.

  16. Sample Collection (1) • 20mls of venous blood will be taken at the following time-points: • Baseline (prior to starting chemotherapy/post registration) • Day 1 of each subsequent cycle of chemotherapy • Where possible, at each follow up visit • Disease progression

  17. Sample Collection (2) • Tubes, labels and worksheets will be provided • Blood samples will be labelled with the patient’s trial no, initials, and the timepoint, date and time the sample was taken • Buffy coats and plasma will be prepared at each collaborating centre and will be stored at -70°C • Collection will be transferred to the Analytical Services Unit, Wolfson Wohl Cancer Research Centre, University of Glasgow, at regular intervals (depending on storage capacity at site • See current version of the Lab Manual for further details

  18. Quality Assurance Quality Assurance will be maintained by the following requirements and activities: • Trial Investigators and Site Staff must ensure that the trial is conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirements • No on site monitoring will be performed however central monitoring of trial data will be performed by the Trial Statistician and the Clinical Trial Co-ordinator • The CTU will control data consistency and data quality by entering trial data onto the CTU trial database. Computerised and manual consistency checks will be performed and queries issued in cases of inconsistency or missing information. A full audit trail of any changes to the database will be maintained • The Trial Management Group will ensure the trial is being managed according to protocol, GCP and regulatory requirements (the Trial Management Group will oversee the running of the study and meet if and when necessary)

  19. Ethical and Regulatory Standards • This study conducted according to ICH GCP guidelines and CR-UK CTU (Glasgow) SOPs • This study is carried out in accordance with the World Medical Association Declaration of Helsinki (1964) and the Tokyo (1975), Venice (1983), Hong Kong (1989), South Africa (1996) amendments

  20. Contact Details CRUK CTU, Glasgow Cancer Research UK Clinical Trials Unit Level 0 Beatson West of Scotland Cancer Centre 1053 Great Western Road Glasgow, G12 0YN Tel: +44(0) 141 301 7215 Fax: +44(0) 141 301 7219 Laura Douglas Liz-Anne Lewsley Clinical Trial Co-ordinator Project Manager Laura.douglas@glasgow.ac.ukLiz-Anne.Lewsley@glasgow.ac.uk

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