NCT04726358|UnknownDMC
ProCaLung: Project on Cancer of the Lung
ProCaLung
ProCaLung - Project on Cancer of the Lung : A National Radiotherapy Quality Assurance for Stage III NSCLC
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ProCaLung
ProCaLung - Project on Cancer of the Lung : A National Radiotherapy Quality Assurance for Stage III NSCLC
Sponsor study identifier
observational
1,000
1 country
5
Study Start
October 1, 2021
Actual (reported)Primary Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
ProCaLung is a national registry collecting radiation treatment parameters of patients having lung cancer that extends to mediastinal lymph nodes. The project includes a peer review activity. The purpose of this public health program is similar to an audit whose objective is to promote quality of radiation oncology in Belgium. It is run by Institut Jules Bordet on behalf of the College of Physicians for Radiotherapy Centers of the Belgian Health Federal Public Service, in close collaboration with the Belgian Cancer Registry. All Belgian radiotherapy centers are invited to participate in ProCaLung but their participation is not mandatory. The centers who accept to participate show a commitment to quality assurance as the radiotherapy-treatment-related parameters they generate will be analyzed to establish national statistics. It includes a peer-review process based on international guidelines for mediastinal nodes delineations given for informational purposes. The public interest program also collects technical parameters as they were planned and delivered during the course of chest radiation treatment. This includes the delineations of tumors, nodes and chest organs on simulation-CT images, PET/CT images, chest-CT images and the clinical information related to the lung cancer. Results/statistics will be published at the end of the project.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2020
Actual (reported)January 27, 2021
Actual (reported)October 1, 2021
Actual (reported)March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
descriptive statistics for quality assurance (no sample size needed)
* Dosimetry \[Non-inferiority, comparison of groups by final review group\]: Mean Lung Dose, Lung V20Gy, Lung V30Gy, Mean Heart Dose, Esophagus V60Gy. * Waiting times, use of contrast-enhanced CT, ITV, overall treatment time, proportion of treatments with recommended organs at risk delineated, radiological treatment completion rate, chemotherapy (and immunotherapy) completion rate, use of static/rotational intensity modulation, availability of data in the electronic health record.
1 year
descriptive statistics for QA (no sample size needed)
\* Waiting times, use of contrast-enhanced CT, ITV, overall treatment time, proportion of treatments with recommended organs at risk delineated, radiological treatment completion rate, chemotherapy (and immunotherapy) completion rate, use of static/rotational intensity modulation, availability of data in the electronic health record.
2 years
Secondary endpoints related to standardization
1 year
Secondary endpoints related to outcomes
2 years
All patients treated with thoracic radiotherapy in Belgium for NSCLC with at least one positive mediastinal node.
GZA Ziekenhuizen (campus Sint-Augustinus)
Antwerp, 2610, Belgium
Institut Jules Bordet
Brussels, 1070, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Sint-Maarten
Mechelen, 2800, Belgium
Luigi Moretti, MD, PhD
Belgian College of Physicians for Radiation Oncology Centers
First Submitted
September 29, 2020
First Posted
January 27, 2021
Study Start
October 1, 2021
Actual (reported)Primary Completion
March 1, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
AZ Turnhout (campus Sint-Elisabeth)
Turnhout, 2300, Belgium
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 12, 2023
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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