Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy

Trial Title: Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy

NCT ID: NCT05808790

Condition: Lung Metastases
Colorectal Cancer Metastatic

Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary

Conditions: Keywords:
Colorectal pulmonary metastases
Pulmonary metastasectomy
Stereotactic radiotherapy
Randomized controlled trial
Colorectal cancer metastases

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Multicenter, parallel-arm, phase III randomized controlled trial Patients will be randomized in a 1:1 manner to SABR or minimally invasive metastasectomy for the local treatment of three or less colorectal pulmonary metastases

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Minimally invasive pulmonary metastasectomy
Description: Surgical margin is equal to tumor size, if possible The goal is a parenchymal-sparing resection
Arm group label: Minimally invasive pulmonary metastasectomy

Other name: Lung metastasectomy

Intervention type: Radiation
Intervention name: Stereotactic ablative radiotherapy
Description: Depending on tumor location, 54 Gy in 3 fractions, 55 Gy in 5 fractions, 60 Gy in 8 fractions.
Arm group label: Stereotactic ablative radiotherapy

Other name: SABR

Other name: Stereotactic body radiation therapy (SBRT)

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

Detailed description: The study is formally endorsed by the Dutch Society of Lung Surgery (NVvL), the Dutch Society of Cardiothoracic Surgery (NVT), the Dutch Society of Radiation Oncology (NVRO). The main objective of the proposed randomized trial is to compare efficacy of SABR to the efficacy of metastasectomy with regards to the primary endpoint (local recurrence free survival at 5 years) in patients with limited colorectal pulmonary metastases. This will determine the most effective local treatment modality. The investigators hypothesize that patients with limited colorectal pulmonary metastases will have non-inferior overall survival after pulmonary metastasectomy compared to SABR, however metastasectomy will result in superior local recurrence free survival at five years when compared to SABR. In addition, the investigators hypothesize that SABR is associated with lower morbidity, comparable quality of life and comparable health care costs compared to metastasectomy. Recurrent metastases are preferably treated by the index treatment to which the patient was randomized, local recurrent metastases are preferably treated by means of cross-over between both arms. Comparing metastasectomy to SABR for patients with colorectal pulmonary metastases will present the international community the evidence needed to better select patients for local radical treatment, while diminishing uncertainty for patients and care givers.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Amsterdam University Medical Center (AUMC)

Address:
City: Amsterdam
Zip: 1081 HZ
Country: Netherlands

Start date: January 1, 2024

Completion date: December 31, 2030

Lead sponsor:
Agency: Amsterdam UMC, location VUmc
Agency class: Other

Collaborator:
Agency: Dutch Cancer Society
Agency class: Other

Source: Amsterdam UMC, location VUmc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05808790