NCT05808790Not yet recruiting
Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy
Colorectal Pulmonary Metastases: Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy: a Phase III Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 394 (estimated)
- First submitted
- 24 Mar 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT05808790
What you commit to
- Study type: Interventional
- Planned participants: 394
- From 1 Jan 2024 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or present metastases outside liver or lungs
- Surgical resection by means of a bilobectomy or pneumonectomy
Other illness
- Concurrent malignant cancer, or history of other malignant cancers within the past 5 years (excluding prespecified low-risk cancers)
Other
- Hilar or mediastinal lymph node metastases
- Poor cardiopulmonary function test
- Inability to treat all colorectal metastases
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam University Medical Center (AUMC) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.