ocal ablation of liver and lung metastases in patients with colorectal cancer after failure of first- or later-line systemic chemotherapy – a prospective trial

• Conditions: C18; C19; C20; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum

• Registration Number: DRKS00006295
• Lead Sponsor: niversitätsklinikum Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-11
• Study Completion: 2016-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Histologically confirmed colorectal cancer with liver, lung and / or lymph node metastases
• progression after chemotherapy
• No more than 2 members with active disease
• primary tumor resected, no evidence of local recurrence
• diameter of the largest liver lesion max. 5 cm, not more than five liver metastases
OR
Diameter of the largest lesion 15cm, not more than three liver metastases
(Satellite metastases near the target lesion excluded)
• No more than three lung metastases with a diameter of max. 5cm
OR
not more than five lesions up to 3 cm diameter
• No more than two distant metastases outside the lung and liver (except bone metastases)
• ECOG performance status = 1
• Karnofsky Index = 70%

Exclusion Criteria

• Cerebral metastasis
• Symptomatic bone metastasis
• peritoneal, pleural carcinosis
• Other malignant diseases
• Life expectancy <6 months
• violation of an inclusion criterion

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival after local percutaneous ablation of colorectal liver and lung metastases in patients with progression under first-line (second/thrid line) chemotherapy compared to survival without progression of systemically treated patients group as part of a matched-pair analysis<br><br>(diagnostic imaging, clinical data and questionnaire)

Secondary Outcome Measures

Name	Time	Method
- Effectiveness/local tumor control (follow up CT and/or MRI every 3 months)<br>- Overall survival and quality of life (EQ-5D) of patients (clinical data, questionnaire every 3 months)<br>- these results will be associated with results from collected blood and tissue samples to identify prognostic factors (e.g. microsatellite instability, mutation status: kras/nras/braf, micro-RNA in blodd and tissue)