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ALICAT

A feasibility study to inform the design of a randomised controlled trial to identify the most clinically and cost effect length of anticoagulation with low molecular weight heparin in the treatment of Cancer Associated Thrombosis

ALICAT is a Phase II, mixed methods feasibility study to inform the design of a randomised controlled trial to identify the most clinically and cost effective length of Anticoagulation with Low molecular weight heparin (LMWH) In the

treatment of Cancer Associated Thrombosis (CAT). The trial has been developed on behalf of the Chief Investigator, Dr Simon Noble, Cardiff University. The trial is sponsored by Cardiff University and funded by NIHR HTA (project reference: 10/1/45//01).

The study has four components:

  • A randomised controlled trial (RCT) comparing ongoing LMWH treatment for CAT vs. cessation of LMWH at six months treatment current licensed practice) in patients with locally advanced or metastatic cancer. Patients will be recruited in two stages. Stage 1 will be considered complete once 62 patients have been registered. If at least 15 out of these 62 participants accept randomisation, then we will continue recruitment in stage 2 of the trial, until 200 patients have been registered in total over a period of12 months. Participants will be randomised to the trial arm (continue treatmentwith LMWH for a further 6 months) or the control arm (stop treatment with LMWH). Participants will be assessed at baseline and at 3 and 6 months after the date of randomisation.
  • A nested qualitative study to explore attitudes towards participating in the study; potential barriers and concerns to participation; factors influencing compliance with self-injecting (where appropriate). Interviews shall be held with patients who do not wish to continue with LMWH; trial participants in the intervention arm; trial participants in the control arm; darers of trial participants; Patients who withdraw from the study.
  • Focus groups with clinicians from oncology, haematology and primary care will explore attitudes to recruiting to the study,to identify the challenges of progressing to a full RCT.
  • A UK wide survey exercise to develop a classification and enumeration system for the CAT models and pathways of care.

The primary endpoints are:

  • Number of eligible patients over 12 months
  • Number of recruited patients over 12 months (target recruitment rate of 30% of eligible patients)
  • Proportion of participants with recurrent VTEs during follow-up

The secondary endpoints are:

  • Completion of trial protocol
  • Quality of life
  • Symptom assessment
  • Attitudes of clinicians and patients

SEWTU Role

Partnership – SEWTU is leading on the UK wide mapping of models of care in Cancer Associated Thrombosis

Study Type

Pilot Randomised Control Trial

Funder

Health Technology Assessment Programme

Status

Open

Themes

NISCHR -Cancer

Study Team

Professor K Hood Key Collaborator, Building Blocks

Dr MJ Bekkers Research Associate, South East Wales Trials Unit

Contact information

Email address
ALICAT@cardiff.ac.uk

Key data

Status
Running
ISRCTN 37913976
ControlledTrials.com
UK Clinical Trials Gateway
EU Clinical Trials Register
Trial number 2012-004117-14
UK Clinical Research Network
Study number 14156
Start date
Sept. 1, 2012
End date
Jan. 31, 2015
Grant value
£616,983
General enquiries
Dr Lisette Nixon
Chief investigators
Dr Simon Noble
Clinical centre
Wales Cancer Trials Unit
Sponsoring body
Cardiff University

External links

Related pages