A Randomized Controlled Trial on Pulmonary Metastasectomy vs. Medical Treatment Alone in Colorectal Cancer Patients with ≥ 3 Lung Metastases (PUCC-Trial)

• Applicant: Dr. Severin Schmid
• Subject Area: General and Visceral Surgery ; Cardiac and Vascular Surgery
• Term: from 2020 to 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 418151269

There is an abundance of retrospective studies showing excellent results after pulmonary metastasectomy (PM) in colorectal cancer patients. These findings led to inclusion of surgery as part of the standard multimodal treatment regimen in selected patients. To date there has not been any evidence beneficial effects from PM in prospective trials and there is a controversy whether the postulated survival benefit is merely due to a selection bias. Furthermore, although there is a wide acceptance for surgery in patients with few metastases, a short disease-free interval and presence of 3 or more metastases are often considered contraindications to a surgical approach. The aim of this study is to determine the effect of PM in addition to medical treatment compared to medical treatment alone in colorectal cancer patients with ≥3 pulmonary metastases with uncertain benefit from resection in a prospective randomizedcontrolled trial. Primary endpoint will be overall survival, secondary endpoints include progression-free survival and quality of life. With strong evidence pointing in either direction surgery can either be implicated as standard treatment also in patients with a higher tumor burden to improve long-term oncologic outcome or overtreatment with usually 2-3 surgeries (bilateral pulmonary and hepatic) can be avoided.

• DFG Programme: Clinical Trials
• Co-Investigators: Dr. Ralph Fritsch; Professor Dr. Bernward Passlick