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Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy

ConditionsLung MetastasesColorectal Cancer Metastatic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimally invasive pulmonary metastasectomy

    Procedure/Surgery

    Surgical margin is equal to tumor size, if possible The goal is a parenchymal-sparing resection

  • Stereotactic ablative radiotherapy

    Radiation

    Depending on tumor location, 54 Gy in 3 fractions, 55 Gy in 5 fractions, 60 Gy in 8 fractions.

Treatment groups

394 Participants
are divided into 2 treatment groups
Group A: Minimally invasive pulmonary metastasectomyActive comparator 1 intervention
Group B: Stereotactic ablative radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local recurrence-free survival

Time from randomization to local recurrence or death from any cause

Time frame
From date of randomization through study completion, up to 10 years

Secondary outcomes

1

Overall survival (OS)

Time from randomization to death from any cause

Time frame
5 years
2

Progression-free survival (PFS)

Time from randomization to disease progression at any site or death

Time frame
5 years
3

Local recurrence rate (LRR) per tumor

Proportion of treated metastases with local recurrence

Time frame
5 years
4

Quality of life (QoL) assessment - EuroQoL (EQ-5D-5L)

\[0-5 for 5 dimensions, higher score = worse QoL\]

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC, location VUmc

Lead sponsor

Dutch Cancer Society

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: