Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808790
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-03-24
Brief Title:
Colorectal Pulmonary Metastases Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Colorectal Pulmonary Metastases Pulmonary Metastasectomy Versus Stereotactic Ablative Radiotherapy a Phase III Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPPER
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None