Condition category
Cancer
Date applied
09/03/2016
Date assigned
09/03/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Ms Julie Croft

ORCID ID

Contact details

University of Leeds
Clinical Trials Research Unit
17 Springfield Mount
Leeds
LS2 9JT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20592

Study information

Scientific title

LAVA: Liver resection surgery versus thermal Ablation for colorectal liVer metAstases

Acronym

LAVA

Study hypothesis

The aim of this study is to compare the effectiveness of liver resection surgery and thermal ablation for the treatment of colorectal liver metastases.

Ethics approval

16/LO/0058

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Surgery; Subtopic: Surgery; Disease: Surgery (All Surgery)

Intervention

Participants are randomly allocated to one of two treatment groups.

Surgical resection: Surgical liver resection will be performed in accordance with each site’s usual practice. Patients may be offered open or laparoscopic liver resection depending on site and stage of disease. Procedures for patients with extensive metastatic disease can include two stage liver resection, venous embolization, or the ALPPS procedure (Associated Liver Partition and Portal vein ligation for Staged hepatectomy).

Thermal ablation: Either radiofrequency ablation (RFA) or microwave ablation (MWA) will be carried out according to the local availability of equipment and expertise. Ablation may be performed at laparoscopic or open surgery if the percutaneous approach is contra-indicated.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Disease free survival at 2 years is calculated from participant assessments at 3, 6, 12, 18 and 24 months post-randomisation.

Secondary outcome measures

1. Local and distant recurrence of disease at 2 years is calculated from participant assessments at 3, 6, 12, 18 and 24 months post-randomisation
2. Overall survival is determined at 2 and 5 years post-randomisation
3. Post treatment complications are recorded at participant assessments at 3, 6, 12, 18 and 24 months post-randomisation.
4. Disease free survival (DFS) (measured from end of intervention) at 2 years post-randomisation
5. Use of subsequent therapies for treatment failure over 2 years post-randomisation
6. Health related quality of life is measured using EQ-5D, EORTC QLQ-C30, EORTC LMC21 at baseline 3 and 6 months post randomisation
7. Length of intensive therapy unit (ITU) and inpatient stay
8. Resource use collected retrospectively at 3, 6, 12, 18, and 24 months post-randomisation

Overall trial start date

01/10/2016

Overall trial end date

30/09/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged ≥ 18 years
2. Able to provide written informed consent
3. MDT diagnosis of colorectal liver metastases considered to be resectable with curative intent
4. Resected colorectal primary or plan for primary resection with curative intent
5. Meets one or more of the following criteria:
5.1. Considered high risk for surgery due to age e.g. Age greater than 75 years of age
5.2. Major co-morbidities as judged by the treating clinician. Examples include history of myocardial infarction, severe chronic airway disease, major cerebrovascular accidents (CVA), pulmonary embolism (PE)
5.3. Liver metastases with poor prognosis and or high risk surgery due to tumour burden, Examples include extensive synchronous disease, need for two stage resection or ALLPS, small anticipated remnant liver volume, resectable or ablatable extra-hepatic disease, downstaged with chemotherapy, poor response after chemotherapy or portal vein embolization but still resectable
6. Suitable candidate for either liver resection surgery or thermal ablation as judged by the MDT
7. Able and willing to comply with the terms of the protocol including QoL questionnaire

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 330; UK Sample Size: 252

Participant exclusion criteria

1. Incurable extra-hepatic metastases
2. Concurrent malignant disease (except basal cell carcinoma)
3. Patients who have undergone previous surgery or ablation for colorectal liver metastases
4. Planned simultaneous resection for primary and liver metastases disease
5. Pregnancy

Recruitment start date

01/10/2016

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Clinical Trials Research Unit 17 Springfield Mount
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

R&D (1st Floor
Maple House)
Rossenheim Building
235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.