PHITT: For Investigators

Paediatric Hepatic International Tumour Trial - PHITT

For copies of the latest and previous versions of documents distributed for this trial, please contact the PHITT Trial Office at phitt@trials.bham.ac.uk.

Change of Staff

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 PHITT Trial Office.

  • Site Registration Form [.pdf]
  • UK Investigator Registration Form [.doc]
  • UK Site Staff Registration Form [.doc]
  • Site Signature Delegation Log v1.0 [.pdf]

Trial Documents

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 PHITT Trials Office.

  • PHITT Protocol v3.0a 17Oct2018 [.pdf]
  • PHITT PIS Trial Entry v1.0a [zip]
  • PHITT PIS Group A+B v2.0 [.zip]
  • PHITT PIS Group C+D v2.0 [zip]
  • PHITT PIS Group E v2.0 + F v3.0 [zip]
  • PHITT Informed Consent Form Trial Entry (Over 16) v1.0 [.pdf]
  • PHITT Informed Consent Form Treatment (Over 16) v1.0 [.pdf]
  • PHITT Informed Consent Form Trial Entry (Parent/Guardian) v1.0 [.pdf]
  • PHITT Informed Consent Form Treatment (Parent/Guardian) v1.0 [.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.

  • PHITT Version Control List v20.0 10-Dec-2018 [.pdf]

Amendments

Below will be  links to documents 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.

  • SA-03 - Urgent Safety Measure Protocol v2.0 [link opens in popup]
  • SA-04 Change of PI Oxford [link opens in popup]
  • SA-05 Change of PI Southampton [link opens in popup]
  • A-06 Non substantial ammendment Protocl v2.0a vd17-Jan-2018 [link opens in popup]
  • SA-07 Addition of new site, Kings College London [link opens in popup]

Case Report Form

  • PHITT Case Report Forms (current) [pdf]

Guidelines

  • PHITT SAE & Expected SAR Form Completion Guidelines v3.0 [.pdf]
  • PHITT Guidelines for site staff on Informed Consent Procedures v1.0 [.pdf] 
  • PHITT CRF Completion Guidelines v1.0 20-Dec-2017 [.pdf]
  • PHITT Trial Online Database User Guide v1.0 vd31-Aug-2018  [.pdf]

Other Trial Documents

  • PHITT Pharmacy Manual v1.0 11-Apr-2017 [.pdf]
  • PHITT Laboratory Manual v4.0 28-Aug-2018 [.pdf]
  • PHITT Biological-Sample Schedule v1.0 21-Jul-2017 [.pdf]
  • Release of Medical Information Form v1.0 30-Jan-2017 [.pdf]

Summary of Product Characteristics

  • CAMPTO 20mg/ml concentrate for solution for infusion 100mg-300mg presentation Mar 2018 [.pdf]
  • Carboplatin 10mg/ml concentrate for solution for infusion 26-Feb-2014 [.pdf]
  • Cisplatin 1mg/ml concentrate for solution for infusion 09-Jan-2015 [.pdf]
  • Doxorubicin 2mg/ml concentrate for solution for infusion 21-Jan-2016 [.pdf]
  • Etoposide 20 mg/ml concentrate for solution for infusion 01-May-2015[.pdf]
  • Fluorouracil 50mg/ml solution for injection or infusion[.pdf]
  • Gemcitabine 100mg/ml concentrate for solution for infusion 01-Nov-2012[.pdf]
  • Nexavar 200mg film-coated tablets 19-Dec-2014[.pdf]
  • Oxaliplatin 5mg/ml concentrate for solution for infusion 10-Jul-2012[.pdf]
  • Vincristine sulphate 1mg/ml solution for injection 13-May-2016[.pdf]

News and Events

Contact Details

Chief Investigator

Professor Bruce Morland                                                                                  

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 1061

Email: Bruce Morland

PHITT Trial Office


Trial Coordinator:  Steve Baker
Trial Administrator:  Duncan Gordon
Data Manager: Neil Werrett
Trial Monitor:  Jennifer Keely
Trial Management Team Leader:  Nicola Fenwick
Trial Statistician:  Nicola Jackson

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

Enquiries

Telephone: +44 (0) 121 414 1061 or +44 (0) 121 415 8211
Fax: +44 (0) 121 414 9520
Email: phitt@trials.bham.ac.uk

Randomisation service supplied by the CRCTU at the University of Birmingham

Randomisation should be performed by sites online at:

https://www.chilternproject.eu/study/CHI

In case of any problems with online randomisation, randomisation can be performed via the telephone by the CRCTU on:

Tel: +44 (0) 121 425 8211 or Tel: +44 (0) 121 415 1061

Serious Adverse Event Reporting

SAE's should be faxed to the PHITT Trial Office, CRCTU, University of Birmingham, UK. Email: reg@trials.bham.ac.uk.

Fax: +44 (0) 121 414 9520 or +44 (0) 121 414 3700

Sponsor

University of Birmingham

CRCTU Home Page

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