Axi-STS Trial: 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 Axi-STS Trial Office.

• Investigator Registration Form [.pdf]
• Trial Staff Registration Form [.pdf]
• Site Signature and Delegation Log [.pdf]
• Site Registration Form [.pdf]

Links to the current protocol, Patient Information Sheet, 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 contact the Axi-STS Trial Office.

• GP Letter [.pdf]
• Patient Information Sheet (New Patients) [.pdf]
• Patient Information Sheet (Current Patients) [.pdf]
• Informed Consent Form (New Patients) [.pdf]
• Informed Consent Form (Current Patients) [.pdf]
• Partner Pregnancy Patient Information Sheet and Consent Form [.pdf]
• Trial Protocol [.pdf]
• Trial Summary [.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.

• Investigaor Site File
  • Document Version Control v.13 [.pdf]
  • Document Version Control v.12 [.pdf]
  • Document Version Control v.11 [.pdf]
  • Document Version Control v.10 [.pdf]
  • Document Version Control v.09 [.pdf]
  • Document Version Control v.08 [.pdf]
  • Document Version Control v.07 [.pdf]
  • Document Version Control v.06 [.pdf]
  • Document Version Control v.05 [.pdf]
  • Document Version Control v.04 [.pdf]
  • Document Version Control v.03 [.pdf]
  • Document Version Control v.02 [.pdf]
  • Document Version Control v.01 [.pdf]
• Pharmacy
  • Pharmacy Document Version Control v.07    17-Feb-2016 [.pdf]
  • Pharmacy Document Version Control v.06 [.pdf]
  • Pharmacy Document Version Control v.05 [.pdf]
  • Drug Order Form v.04 [.pdf]
  • Drug Order Form v.03 [.pdf]
  • Pharmacy Manual v.02 [.pdf]
  • Pharmacy Manual v.01 [.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.

All amendments open a new page.

REC

• Amendment 11 12-Apr-2016
• Modification to Amendment 08 2
• Amendment 08 24-Mar-2014 
• Amendment 03 27-Sep-2011 
• Amendment 02 16-May-2011
• Amendment 02 24-Jan-2001

MHRA

• Amendment 11 12-Apr-2016
• Amendment 10 01-Dec-2014
• Amendment 08 24-Mar-2014 
• Amendment 04 30-Jul-2012
• Amendment 02 16-May-2011
• Amendment 02 24-Jan-2011
• Amendment 01 11-Jan-2010

Case Report Form

• Baseline Assesments [.pdf]
• Baseline Disease Evaluation Form [.pdf]
• Clinical Evaluation Form [.pdf]
• Coded Tables [.pdf]
• Con Meds Form [.pdf]
• Deviation and Withdrawal Form [.pdf]
• Disease Evaluation Form [.pdf]
• Eligibilty Check List [.pdf]
• Follow up Form [.pdf]
• Notification of Death Form [.pdf]
• Patient Diary Front Cover [.pdf]
• Patient Diary [.pdf]
• Pfizer Fax Cover Sheet [.pdf]
• Post Treatment Form [.pdf]
• Pregnancy Notification Form [.pdf]
• Registration Form [.pdf]
• SAE Fax Cover Sheet [.pdf]
• Serious Adverse Event Form [.pdf]
• Treatment Form Cycle 1 [.pdf]
• Treatment Form Cycle 2 [.pdf]
• 12 Weeks Disease Evaluation Form [.pdf]

Guidelines

• Blood Collection v.01 [.pdf]
• Pathology Collection v.01 [.pdf]
• Fresh Sample Collection v.01 [.pdf]
• Trial Guidance v.01 [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]

Lay Summary of Results 

Oral presentation of results for the Leiomyosarcoma and Other cohorts, CTOS 19^th Annual Meeting, 15-18 October 2014, Berlin, Germany.

Poster presentation of results for the Leiomyosarcoma and Other cohorts, NCRI conference, 2-5 November 2014, Liverpool, UK.

Chief Investigator

Proffesor Penella Woll
University of Sheffield,
Weston Park Hosptial,
Whitham Road,
Sheffield,
S10 2SJ

AdUP Trial Office

Trial Coordinator:                                Ana Hughes
Trial Administrator:                            Penny Goodby
Trial Monitor:                                      Kavita Mistry
Trial Management Team Leader:      Clive Stubbs
Trial Statistician:                                Piers Gaunt

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

Enquiries

Telephone: +44 (0)121 4143793 or +44 (0)121 414 5102
Fax: +44 (0)121 414 2230
Email: axi-sts@trials.bham.ac.uk

Trial Entry

Telephone: (0)800 371 969              (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting

Fax: +44 (0)121 414 2230 or +44 (0)121 414 3700

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust
Research Department
11 Broomfield Road
Sheffield S10 2SE