TUXEDO: 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 TUXEDO Trial Office.

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Delegation log [.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 TUXEDO Trial Office.

• Protocol v3.0 [.pdf]
• Patient Information Sheet v4.0 [.pdf]
• Informed Consent Form v3.0 [.pdf]
• GP Letter v2.0 [.pdf]

Version Control Lists

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

• Version Control Document
  • Version Control Checklist - Investigator Site Folder V5.0 01-Dec-2016 [.pdf]
  • Version Control Checklist - Investigator Site Folder v4.0 21-Sep-2015 [.pdf]
  • Version Control Checklist - Investigator Site Folder v3.0 10-Feb-2015 [.pdf]
  • Version Control Checklist - Investigator Site Folder v2.0 02-Dec-2014[.pdf]
  • Version Control Checklist - Investigator Site Folder v1.0 Oct-2012[.pdf]
• Pharmacy Version Control
  • Pharmacy Version Control V7.0 [.pdf]
  • Pharmacy Version Control V6.0 [.pdf]
  • Pharmacy Version Control V5.0 [.pdf]
  • Pharmacy Version Control V4.0 [.pdf]
  • Pharmacy Version Control V3.0 09-Dec-2014 [.pdf]
  • Pharmacy Version Control V2.0 12-Oct-2012 [.pdf]
• CRF Version Control
  • CRF Version Control V2 22-Mar-2016 [.pdf]
  • CRF Version Control V1 9-Feb-2016 [.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.

• Amendment 1
• Amendment 2 
• Amendment 3
• Amendment 4
• Amendment 5
• Amendment 6
• Amendment 7

Case Report Form

• Registration Form v8.0 [.pdf]
• Eligibility Form v8.0 [.pdf]
• Baseline Asessments Form v7.0 [.pdf]
• Biochemistry Form v4.0 [.pdf]
• Haematology Form v4.0 [.pdf]
• Imaging and Staging Form v5.0 [.pdf]
• Medical History Form v6.0 [.pdf]
• Neo-Adjuvant Treatment Form v5.0 [.pdf]
• Physical Examination Form v3.0 [.pdf]
• Primary Cystoscopic Findings v4.0 [.pdf]
• Non Trial Conomitant Medication Form v3.0 [.pdf]
• Trial Specific Concomitant Medication Form v3.0 [.pdf]
• Mitomycin C and 5FU Dose Form v3.0 [.pdf]
• Cetuximab Dose Form v4.0 [.pdf]
• Radiotherapy Treatment Form v3.0 [.pdf]
• 30 Days Post Treatment Form v7.0 [.pdf]
• Follow-up Form - 3 Months v4.0 [.pdf]
• Follow-up Form - 6 Months v4.0 [.pdf]
• Follow-up Form - 10 Months v4.0 [.pdf]
• Follow-up Form - 16 Months v4.0 [.pdf]
• Adverse Events Forms v3.0 [.pdf]
• Cystectomy Form v4.0 [.pdf]
• Local Disease Assesment Form v5.0 [.pdf]
• Metastatic Disease Form v4.0 [.pdf]
• Second Primary Cancer Form v3.0 [.pdf]
• SAE Form v3.0 [.pdf]
• SAE Fax Cover Sheet v2.0 [.pdf]
• Withdrawal Form v4.0 [.pdf]
• Discontinuation v3.0 [.pdf]
• Deviation Form v5.0 [.pdf]

Guidelines

• CRF Completion Guidelines v2.0 [.pdf]
• SAE Form Completion Guidelines v2.1 [.pdf]
• Guidelines on Informed Consent Procedures v2.0 [.pdf]
• Radiotherapy Planning Guidelines v2.0 [.pdf]

Other Trial Documents

• Pharmacy Manual v5.0 [.pdf]
• Quality of Life Questionnaire [.pdf]
• Reference Safety Information [.pdf]
• Cetuximab SPC http://www.medicines.org.uk/emc/medicine/19595
• Fluorouracil SmPC http://www.medicines.org.uk/emc/medicine/25800
• Mitomycin C SPC  http://www.medicines.org.uk/emc/medicine/26917

To Date there are no Publications for this Trail.

• Newsletter November 2015 [.pdf]
• Newsletter April 2016 [.pdf]

Chief Investigator
Professor Nicholas James
Cancer Centre, 3rd Floor
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH

Tel:       0121 371 3615
Fax:      0121 371 3602
Email:  Nicholas.James@uhb.nhs.uk

In Warwick:
Director of the Cancer Research Unit
Clinical Trials Unit
Gibbet Hill Campus
University of Warwick
Coventry
CV4 7AL

Tel: 0 2476 574 365 (Alaine Richards, PA)
Tel:  0 2476 572 815 (Direct line)
Email:  n.d.james@warwick.ac.uk

TUXEDO Trial Office
Trial Coordinator:                             Baljit Kaur
Trial Monitors:                                  Kavita Mistry

Trial Management Team Leader: Sarah Bowden
Trial Statistician:                              Dr Laura Buckley

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

Enquiries
Telephone:   +44 (0)121 414 5102
Fax:              +44 (0)121 414 2230
Email: tuxedo@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
University of Birmingham