CompARE

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 CompARE Trial Office.

• Investigator Registration Form [.pdf]
• Pathologist Registration Form [.pdf]
• Site Staff Registration Form [.pdf]

Links to the current Protocol and Patient Documents 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. Case Report Forms, Serious Adverse Event Form, Guidelines, Patient Questionnaires, Amendments, etc.) can be found by clicking on the other menu items below. If you cannot find what you are looking for, please contact the CompARE Trial Office. 

• Protocol [.pdf]
• Trial Synopsis [.pdf]

Patient Documents

• Patient Information Sheet E [.pdf]
• Patient Summary Sheet [.pdf]
• Informed Consent Form A [.pdf]
• Informed Consent Form D [.pdf]
• Informed Consent Form CompARE Collect [.pdf]
• GP Letter [.pdf]
• Release of Medical Information Form [.pdf]

Guidelines

• Pharmacy Manual [.pdf]
• SAE Form Completion Guidelines [.pdf]
• Blood and Oral Fluid Sample collection guidelines [.pdf]
• Tissue sample collection guidelines [.pdf]

 

CRF & eRDC Guidelines:

• CRF Completion Guidelines [.pdf]
• CRF Timeline Guidelines [.pdf]
• eRDC User Manual [.pdf]
• eRDC User Tips - CRF Management [.pdf]
• eRDC User Tips - Navigating [.pdf]
• eCRF Guidelines - Completing the Treatment Toxicity Form (for Arms 1 & 3) [.pdf]
• eCRF Guidelines - Completing the Arm 5 Toxicity Form [.pdf]

Other Trial Documents

• Quality of Life Questionnaires:
  • Baseline Questionnaire Pack [.pdf]
  • Arm 1, 4 & 5 End of Concomitant Chemoradiotherapy Questionnaire Pack [.pdf]
  • Arm 3 End of Dose Escalated Questionnaire Pack [.pdf]
  • Arm 4 End of Surgery Questionnaire Pack [.pdf]
  • Arm 5 End of Induction Durvalumab Questionnaire Pack [.pdf]
  • Arm 5 End of Adjuvant Durvalumab Questionnaire Pack [.pdf]
  • Follow-up 3 & 6 Months Questionnaire Pack [.pdf]
  • Follow-up 12 & 18 Months Questionnaire Pack [.pdf]

• Summary of Product Characteristics:
  • Carboplatin 10mg [.pdf]
  • Cisplatin 1mg [.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 14, 14-Aug-2018 [opens new page]
• Amendment 03, 07-Dec-2015 [opens new page]
• Amendment 02, 12-Oct-2015 [opens new page]
• Amendment 01, 15-Jul-2015 [opens new page]

Version Control Lists

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

• Version Control List V36 - Investigator Site File [.pdf]
• Version Control List V15 - Pharmacy File [.pdf]

Newsletters

Current Newsletter

• Newsletter - Summer 2022 [.pdf]

Previous Newsletters

• Newsletter - January 2018 [.pdf]
• Newsletter - May 2018 [.pdf]
• Newsletter - November 2018 [.pdf]
• Newsletter - Spring 2019 [.pdf]
• Newsletter - Summer 2019 [.pdf]
• Newsletter - Winter 2019 [.pdf]
• Newsletter - Spring 2022 [.pdf]

Chief Investigator

Professor Hisham Mehanna, Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham. B15 2TT

Tel: +44 (0)121 414 6547

CompARE Trial Office

Senior Trial Coordinator: Isla Humphreys
Trial Coordinator: Annabell Allen 
Data Manager:

Trial Monitor: Alexandra Bryant 
Trial Management Team Leader: Claire Gaunt
Trial Statistician: Piers Gaunt

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

Enquiries

Tel: +44 (0)121 414 5101
Email: CompARE@trials.bham.ac.uk

Trial Entry

Tel: +44 (0)121 414 5101  & +44 (0)121 414 9247  (9:00 am till 5:00 pm Monday to Friday)

Serious Adverse Event Reporting

Email: reg@trials.bham.ac.uk

Sponsor

University of Birmingham