ProCaLung: Project on Cancer of the Lung

Locally Advanced Lung Carcinoma Clinical Trial

— ProCaLung  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726358
• Other study ID #: 2019-42
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: September 2022
• Source: Jules Bordet Institute
• Contact: Luigi Moretti, MD, PhD
• Phone: +3225413800
• Email: Luigi.moretti[@]bordet.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Lung Carcinoma
• Lung Neoplasms

Locations

Country	Name	City	State
Belgium	GZA Ziekenhuizen (campus Sint-Augustinus)	Antwerpen
Belgium	Institut Jules Bordet	Brussels
Belgium	UZ Gent	Gent
Belgium	AZ Sint-Maarten	Mechelen
Belgium	AZ Turnhout (campus Sint-Elisabeth)	Turnhout

Sponsors (3)

Lead Sponsor	Collaborator
Jules Bordet Institute	Belgian Cancer Registry, Belgian Federal Public Service, Food Chain Safety and Environment

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	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