Ependymoma: For Investigators

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. Return both documents to the Ependymoma II Trial Office.

• UK Investigator Registration Form [.pdf]

• UK Site Staff Registration Form [.pdf]

Links to the current protocol, Patient Information Sheet and Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below.

If you cannot find what you are looking for please email the Ependymoma II Trials Office.

• SIOP Ependymoma II Protocol v3.0 2017-01-17 [.pdf]

• SIOP Ependymoma II PIS [opens new page]

• SIOP Ependymoma II ICF [opens new page]

• SIOP Ependymoma II GP Letters [opens new page]

• SIOP Ependymoma II QoL [opens new page]

• SIOP Ependymoma II Patient Diary [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control Log. Links to the Version Control Lists used in this trial are below in reverse date order.

• SIOP Ependymoma II Version Control List v3.0 12-Oct-2017 [.pdf]

Amendments

Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• SIOP Ependymoma II Amendment SA-01 [opens new page]
• SIOP Ependymoma II Amendment SA-02 [opens new page]
• SIOP Ependymoma II Amendment SA-03 [opens new page]
• SIOP Ependymoma II Amendment SA-04 [opens new page]
• SIOP Ependymoma II Amendment SA-05 [opens new page]

• SIOP Ependymoma II Non Substantial Amendment NSA-01 [opens a new page]

Case Report Form

• SIOP Ependymoma II Case Report Forms (current) [pdf]

Pharmocovigalance

• SIOP Ependymoma II SAE Form [.pdf]

• SIOP Ependymoma II SAE Reporting Procedure [.pdf]

Guidelines

• SIOP Ependymoma II eCRF Completion Guidelines [.pdf]

• SIOP Ependymoma II Image Transfer Guidelines v1.0 11-Jan-2016 [.pdf]

• SIOP Ependymoma II Pathology Transfer Guidelines v1.0 11-Jan-2016 [.pdf]

• SIOP Ependymoma II Inclusion Procedures [opens new page]

Other Trial Documents

• SIOP Ependymoma II Pharmacy Manual v4.0 07-Jul-2015 [.pdf]

Summary of Product Characteristics

• Carboplatin 10 mg/ml concentrate solution for infusion [.pdf]

• Cisplatin 1 mg/ml concentrate solution for infusion [.pdf]

• Cyclophosphamide Injection 1 g [.pdf]

• Etoposide 20 mg/ml concentrate for solution for infusion [.pdf}

• Methotrexate 25 mg/ml solution for injection [.pdf]

• Sodium valproate [.pdf]

• Vincristine sulphate, solution for injection 1 mg/ml [.pdf]

 Newsletters and Events will be updated throughout the length of the SIOP Ependymoma trial.

Chief Investigator

Professor Richard Grundy                                                                                 

Cancer Research UK Consultant in Paediatric Oncology

Cancer Research UK Clinical Trials Unit (CRCTU)
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Tel: +44 (0) 121 414 7581

Email: richard.grundy@nottingham.ac.uk

SIOP Ependymoma Trial Office

Trial Coordinator:  Eileen Grimes
Trial Monitor: Saika Kauser  
Trial Management Team Leader:  Anna Lawson
Trial Statistician: Daniel Slade

Cancer Research UK Clinical Trials Unit (CRCTU)
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries

Telephone: +44 (0) 121 414 7581 
Fax: +44 (0) 121 414 9520
Email: ependymoma@trials.bham.ac.uk

Trial Entry

Randomisation should be performed via RDE system at:

www.siopependymoma2.com

Serious Adverse Event Reporting

SAE's reported directly to Sponsor Safety Desk:

Fax: +33 9 81 40 42 80 or +33 4 78 78 27 15

Sponsor

Centre Leon Berard, 28 rue Laennec, 69008, Lyon, FRANCE

UK Coordinating Sponsor

University of Birmingham

CRCTU Home Page

http://www.birmingham.ac.uk/crctu