Acticca-01: For Investigators

ACTICCA-1: Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma. A randomized, multidisciplinary, multinational AIO/DGAV/DGVS phase III trial.


For copies of the latest and previous versions of documents distributed for this trial, please contact the Acticca Trial Office at ACTICCA-01@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 Trial Office.

  • Investigator Registration Form [DOCX, 50kb]
  • Site Staff Registration Form [DOCX, 735kb]

Trial Documents

Links to the current protocol, Patient Information Sheet(s), Informed Consent Form(s) 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 ACTICCA-1 Trial Office.

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control List. 

Investigator Site File Version Control Lists

  • v1.0 15-02-2016 Version of ISF Version Control List [PDF, 246kb]
  • v2.0 23-02-2016 Version of ISF Vesion Control List [PDF, 245kb]
  • v3.0 13-04-2016 Version of ISF Version Control List [PDF, 245kb]
  • v4.0 15-4-2016 Version of ISF Version Control List [PDF, 245kb]
  • v5.0 29-4-2016 Version of ISF Version Control List [PDF, 248kb]
  • v6.0 20-7-2016  Version of ISF Version Control List [PDF, 248kb]
  • v7.0 2016.9.13 ISF version control list [PDF, 249kb]
  • v8.0 2016.10.17 ISF version control list  [PDF, 251kb]
  • v9.0 2016.11.15 ISF version control list  [PDF, 251kb]
  • v10.0 2016.2.16 ISF version control list  [PDF, 251kb]
  • v11.0 2017.2.28 ISF version control list [PDF, 251kb]
  • v12.0 2017.3.27 ISF version control list [PDF, 252kb]
  • v13.0 2017.5.3 ISF version control list [PDF, 253kb]
  • v14.0 2018.4.27 ISF version control list [PDF, 254kb]
  • v15.0 2018.09.24 ISF version control list  [PDF, 255kb]
  • v16.0 2019.02.20 ISF version control list [PDF, 257kb]
  • v17.0 2019.05.07 ISF version control list [PDF, 396kb]
  • v18.0 2019.06.24 ISF version control list [PDF, 397kb]
  • v19.0 2023.07.03 ISF version control list [PDF, 740kb]

Pharmacy File Version Control Lists

  • v1.0 25-02-2015 Pharmacy File Version Control [PDF, 237kb]
  • v2.0 23-02-2016 Pharmacy File Version Control [PDF, 237kb]
  • v3.0 13-04-2016 Pharmacy File Version Control [PDF, 237kb]
  • v4.0 15-04-2016 Pharmacy File Version Control [PDF, 237kb]
  • v5.0 29-04-2016 Pharmacy File Version Control [PDF, 239kb]
  • v6.0 20-07-2016 Pharmacy File Version Control [PDF, 239kb]
  • v7.0 2016.9.13 Pharm File version control [PDF, 240kb]
  • v8.0 2016.10.17 Pharm File version control [PDF, 241kb]
  • v9.0 2016.11.15 Pharm File version control [PDF, 241kb]
  • v10.0 2017.2.16 Pharm File version control [PDF, 243kb]
  • V11 2018.09.24 Pharm File Version control List [PDF, 244kb]
  • V12 2019.02.20 Pharm File Version Control List [PDF, 245kb]
  • V13 2019.05.07 Pharm File Version Control List [PDF, 384kb]
  • V14 2019.06.24 Pharm File Version Control List  [PDF, 385kb]

Amendments

Summary of Amendments [PDF, 483kb] - a list 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.

Case Report Form

Guidelines

  • eCRF FAQs [PDF, 174kb]

  • SAE Completion Guidelines [PDF, 212kb]

Newsletters

UK

International

Other Trial Documents

  • Pharmacy Manual [PDF, 449kb]
  • UK Laboratory Manual [PDF, 1121kb]

  • Summary of Product Characteristics:

  • IMP open label [PDF, 93kb]
  • Capecitabine Patient Diary  [PDF, 42kb]
  • Questionnaires:
    • EORTC_INFO25 and SDM-Q-9 [PDF, 188kb]
    • EORTC_QLQ_C30 and BIL21 [PDF, 250kb]
    • SDM-Q-DOC [PDF, 143kb]
  • Patient Cards [PDF, 234kb]
  • InExclusion Criteria Worksheet [PDF, 246kb]
  • Randomisation Criteria Worksheet [PDF, 132kb]
  • Deviation Form [DOCX, 188kb]
  • Template Note to File [DOCX, 217kb]

Publications

There are currently no publications for this trial.

News and Events

  • International Newsletter February 2017 [PDF, 544kb]
  • UK Newsletter February 2017 [PDF, 127kb]
  • UK Newsletter March 2018 [PDF, 142kb]

Contact Details

UK National Coordinator
John Bridgewater

Overall German Trial Coordinator
Dr Alexander Stein
University Medical Center Hamburg-Eppendorf

UK Trial Coordinator
Bishnupriya Bhattacharya 

UK Trial Management Team Leader
Sarah Bowden

eCRF access problems:

UK Trial Monitor
Monitoring Team, CRCTU, University of Birmingham

Overall German Trial Statistician
Eik Vettorazzi
University Medical Center Hamburg-Eppendorf

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

UK Enquiries
Telephone: +44 (0)121 414 3973
Email: ACTICCA-01@trials.bham.ac.uk
German Email Contact: acticca@uke.de

Trial Entry
Please enrol patients via https://acticca-login.xclinical.net/idp/

Serious Adverse Event Reporting
Fax:  +49-40-524719-222

Sponsor
University of Birmingham
Edgbaston
Birmingham
B15 2TT