CANTATA

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 CANTATA 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 CANTATA Trial Office.

• Protocol v3.0 [.pdf]
• Patient Information Sheet v4.0 [.pdf]
• Informed Consent Form v1.0 [.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 Checklist - Investigator Site Folder v3.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v7.0 [.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 4 (opens new page)
• Amendment 1 (opens new page)

Case Report Form

• Randomisation Form v2.0 [.pdf]
• Eligibility Form v2.0 [.pdf]
• Baseline Form v2.0 [.pdf]
• Treatment Form v2.0 [.pdf]
• Concomitant Medication Form v2.0 [.pdf]
• Adverse Events Form v1.0 [.pdf]
• Treatment Discontinuation Form v2.0 [.pdf]
• Skeletal Related Events Form v1.0 [.pdf]
• Withdrawal Form v2.0 [.pdf]
• Notification of Death Form v2.0 [.pdf]
• Deviation Form v1.0 [.pdf]
• Follow Up Form v2.0 [.pdf]
• SAE Form v2.0 [.pdf]

Guidelines

• CRF Completion Guidelines v2.1 [.pdf]
• SAE Form Completion Guidelines v1.0 [.pdf]

Other Trial Documents

• Pharmacy Manual v3.0 [.pdf]
• Quality of Life Questionnaire v1.0 [.pdf]
• SAE Fax Cover Sheet v1.0 [.pdf]

Summary of Products Characteristics

• cabazitaxel (14-Aug-2014) [.pdf]
• docetaxel (07-May-2014) [.pdf]

To date there are no publications for this trial.

No current news or upcoming events

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

Tel:      +44 (0)121 371 3615 (Christine Hillman, Med Sec)
Fax:     +44 (0)121 371 3602
Email: Nicholas.James@uhb.nhs.uk

CANTATA Trial Office
Trial Coordinator:                              Nick Martin
Data Manager:                                   John Mason 
Trial Monitor:                                     Poonam Patel
Trial Management Team Leader:     Clive Stubbs
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 6372
Fax:             +44 (0)121 414 2230
Email:          cantata@trials.bham.ac.uk

Trial Entry
Telephone: +44 (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