Microwave Ablation Versus Stereotactic Body Radiotherapy for Colorectal Liver Metastases in Oligometastatic Disease: a Prospective, Randomised, Phase 2 Trial

NCT03654131 | Active Not Recruiting Phase 2

• 1 other identifier: H-18000085
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The LAVA-CRLM trial (Local Ablation Versus Ablative radiotherapy in ColoRectal Liver Metastases) is a prospective, randomised, phase 2 study designed to compare local control and safety of microwave ablation (MWA) versus stereotactic body radiotherapy (SBRT)in patients with colorectal liver metastases and oligometastatic disease. Primary endpoint is freedom form local lesion progression.

Conditions

Liver Metastases; Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Freedom from local lesion progression (analyzed on patient-level)

  * Defined as the time from randomization to local progression * Censoring: death from any cause, last follow-up * No censoring on disease progression outside of the treated lesions * Local lesion progression is defined as \>20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions

  1 year

Secondary Outcomes (3)

• Overall survival

  From enrollment to 01/01/2026 - minimum follow-up 1 year after treatment for all randomised patients.

• ≥ grade 3 toxicity potentially associated with the treatment

  1 month after treatment

• Toxicity profile as descriptive statistics

  From enrollment to last follow-up 5 years after treatment

Study Arms (2)

MWA

ACTIVE COMPARATOR

Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment.

Device: MWA

SBRT

ACTIVE COMPARATOR

3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy.

Radiation: SBRT

Interventions

MWA DEVICE

Patients are allocated to one of the two arms in a 1:1 randomization

MWA

SBRT RADIATION

Patients are allocated to one of the two arms in a 1:1 randomization

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of
• non-resectability
• small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
• previous extensive liver surgery
• comorbidity
• The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
• Tumor sizes ≤4.0 cm
• Age \> 18 years
• Signed informed consent

You may not qualify if:

• Previous radiotherapy to the liver
• Liver volume \< 700 ml
• Another active cancer disease within the past 36 months
• Not able to understand written or oral protocol information

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Righospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Model Details: SBRT for oligometastases in the liver from colorectal cancer patients. Standard considered MWA.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 31, 2018
• Study Start: July 25, 2018
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 3, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication of all analyses of the primary and secondary trial endpoints and until 5 years after.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose for individual participant data meta-analysis. For this please contact the principal investigator of the trial. Data sharing will be conducted in accordance with Danish law on the processing of personal data, regulations of the Danish Data Protection Authority, and applicable health legislation. Contact Principal investigator Signe Lenora Risumlund Senior Oncologist Department of Oncology, Blegdamsvej 9, 2100 Copenhagen, Capital Region of Denmark, Denmark Signe.lenora.risumlund@regionh.dk

Locations

DK (1)