A Randomized Controlled Trial on Pulmonary Metastasectomy vs. Standard of Care in Colorectal Cancer Patients with = 3 Lung Metastases

Not Applicable

• Conditions: C18.4; C78.0; Transverse colon; Secondary malignant neoplasm of lung

• Registration Number: DRKS00024727
• Lead Sponsor: niversitätsklinikum FreiburgKlinik für Thoraxchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-23
• Study Completion: 2024-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Histologically confirmed colorectal adenocarcinoma
2. = 3 technically resectable (R0) pulmonary metastases
3. Male or female patients aged = 18 years without upper age limit
4. Resected primary tumour with intent to cure (sole prior (chemo) radiation of a rectal cancer with documented complete remission is permitted)
5. In case of previous treatment of hepatic metastases: no radiologic
sign of residual hepatic disease at the time of trial randomisation
6. A minimum of 12 weeks of systemic therapy with the last treatment applied within 6 months prior to randomisation
7. Good performance status (ECOG 0-1)

Exclusion Criteria

1. Active extra-thoracic disease (including primary tumour in situ)
2. Prior resection of lung metastases
3. Requirement of a pneumonectomy to achieve complete resection
4. Other malignancy in the past 5 years (except non-melanoma skin cancer or in situ cancer)
5. Histologically proven intrathoracic lymph node metastasis (except resectable single level mediastinal, hilar and pulmonary)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival (OS)

Secondary Outcome Measures

Name	Time	Method
- Progression-free survival (PFS)<br>- Complete remission<br>- Quality of life (EORTC QLQ-C30, QLQ-CR29 and QLQ-LC29)<br>- Safety (Arm A only)