Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver

Liver Metastases Clinical Trial

Official title:

Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver - a Randomized Phase II Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03654131
• Other study ID #: H-18000085
• Status: Recruiting
• Phase: Phase 2
• Start date: July 25, 2018
• Est. completion date: July 25, 2026

Study information

• Verified date: January 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized phase II trial between microwave ablation (MWA) and stereotactic body radiotherapy (SBRT) - two standard treatment modalities for colorectal patients with metastatic disease in the liver. Primary endpoint is freedom form local lesion progression.

Description:

Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 25, 2026
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of

1. non-resectability

2. small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection

3. previous extensive liver surgery

4. comorbidity

2. 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.

3. Tumor sizes =4.0 cm

4. Age > 18 years

5. Signed informed consent

Exclusion Criteria:

1. Previous radiotherapy to the liver

2. Liver volume < 700 ml

3. Another active cancer disease within the past 36 months

4. Not able to understand written or oral protocol information

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms
• Liver Metastases
• Neoplasm Metastasis

Intervention

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

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

Locations

Country	Name	City	State
Denmark	Righospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Secondary	Overall survival	Defined as the time from randomization to death from any cause; Censoring: last follow-up	3 years
Secondary	Freedom from local lesion progression (analyzed on lesion-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	3 years
Secondary	= grade 3 toxicity potentially associated with the treatment	Defined as the time from randomization to first = grade 3 toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0; Censoring: death from any cause, last follow-up	3 years
Secondary	Toxicity profile as descriptive statistics	Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	3 years
Secondary	Quality of life as descriptive statistics: EORTC QLQ-C30	Using EORTC QLQ-C30	3 years