Minimally invasive pulmonary metastasectomy: Surgical margin is equal to tumor size, if possible The goal is a parenchymal-sparing resection
Stereotactic ablative radiotherapy: Depending on tumor location, 54 Gy in 3 fractions, 55 Gy in 5 fractions, 60 Gy in 8 fractions.
Study summary
COPPER is an international, multicenter, parallel-arm, phase III randomized controlled trial comparing two local treatment strategies (SABR or metastasectomy) for patients with an indication for local treatment for limited (max. three) colorectal pulmonary metastases
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG)-Performance status 0 - 2
* Willing to provide informed consent
* Patients with 1 to 3 lung metastases from colorectal cancer eligible for both a minimally invasive surgical resection and SABR, as assessed by the multidisciplinary tumor board (MDT)
* Radically treated primary colorectal cancer
* Patient is able and willing to complete the quality-of-life questionnaires
* Previous liver metastases are radically treated with curative intent
* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
Exclusion Criteria:
* Previous or present metastases outside liver or lungs
* Concurrent malignant cancer, or history of other malignant cancers within the past 5 years (excluding prespecified low-risk cancers)
* Hilar or mediastinal lymph node metastases
* Poor cardiopulmonary function test
* Inability to treat all colorectal metastases
* Surgical resection by means of a bilobectomy or pneumonectomy
Primary outcome measure(s)
Local recurrence-free survival — From date of randomization through study completion, up to 10 years Time from randomization to local recurrence or death from any cause
Trial sites (1)
Facility
City
Region
Status
Amsterdam University Medical Center (AUMC)
Amsterdam
Netherlands
More Amsterdam UMC, location VUmc trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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