ProCaLung: Project on Cancer of the Lung (ProCaLung)

ProCaLung - Project on Cancer of the Lung : A National Radiotherapy Quality Assurance for Stage III NSCLC

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Lung Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Luigi Moretti, MD, PhD; Phone Number: +3225413800; Email: Luigi.moretti@bordet.be
• Study Contact Backup: Name: Thomas Descamps, MD; Phone Number: +325413800; Email: Thomas.descamps@bordet.be

Study Locations

• Belgium
  • Antwerpen, Belgium, 2610
    • Recruiting
    • GZA Ziekenhuizen (campus Sint-Augustinus)
  • Brussels, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet
  • Gent, Belgium, 9000
    • Recruiting
    • UZ Gent
  • Mechelen, Belgium, 2800
    • Recruiting
    • Az Sint-Maarten
  • Turnhout, Belgium, 2300
    • Recruiting
    • AZ Turnhout (campus Sint-Elisabeth)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients treated with thoracic radiotherapy in Belgium for NSCLC with at least one positive mediastinal node.

Description

Inclusion Criteria:

• Histologically confirmed NSCLC only
• Locally advanced disease (Stage III) with positive mediastinal nodes
• PET/CT staged
• Curative intent radiotherapy
• Chemotherapy (ChT): Without, Sequential ChT - Radiotherapy (RT) (max 2 cycles), Concurrent (± induction ChT)
• Prescription dose ≥ 60 Gy (EQD2)

Exclusion Criteria:

• Prior history of thoracic RT
• Malignant pleural effusion
• History of malignancy in the last 3 years, except basal-cell skin cancer and intra-epithelial neoplasia
• Progression after induction chemotherapy
• Use of concurrent targeted, immunomodulating or anti-angiogenic agents except if the patient is included in a clinical trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints related to standardization	[Superiority, basis of sample size calculation] CTVn Hausdorff distance 95th percentile (HD95p) > 3mm, calculated between the initial contour of the radiotherapy (RT) center and ProCaLung's review for start and end cohorts.; Proportion of treatments with initial review group 1 or 2 in start and end cohorts.; Proportion of treatments with final review group 1 or 2 in start and end cohorts.; Distribution of indicators of change in start and end cohorts.; Conversion rates of review group 3a to review group 1, review group 4 to review group 1, and review group 4 to review group 3a.; Distribution of the reasons for the impossibility to review the target definition.	1 year
Secondary endpoints related to outcomes	Toxicity [Comparison of final review groups]: Grade 3+ esophageal toxicity, Grade 3+ pulmonary toxicity (clinical and radiological), Other Grade 3+ toxicity.; Pattern of locoregional failure (including relation to CTV),; Progression free survival; Overall survival.	2 years

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Collaborators: Belgian Federal Public Service, Food Chain Safety and Environment; Belgian Cancer Registry
• Investigators: Study Chair: Luigi Moretti, MD, PhD, Belgian College of Physicians for Radiation Oncology Centers

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: NSCLC; Radiation therapy; Quality assurance; Mediastinal adenopathy; Delineation; National registry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2019-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No