Clinical trial NCT04726358: ProCaLung: Project on Cancer of the Lung
Official title: ProCaLung - Project on Cancer of the Lung : A National Radiotherapy Quality Assurance for Stage III NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locally Advanced Lung Carcinoma
Keywords: NSCLC
Radiation therapy
Mediastinal adenopathy
Quality assurance
Delineation
National registry
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
Collaborators: name: Belgian Federal Public Service, Food Chain Safety and Environment
name: Belgian Cancer Registry
First posted: 2021-01-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with thoracic radiotherapy in Belgium for NSCLC with at least one positive mediastinal node.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: descriptive statistics for quality assurance (no sample size needed)
timeFrame: 1 year
measure: descriptive statistics for QA (no sample size needed)
timeFrame: 2 years
Secondary outcomes:
measure: Secondary endpoints related to standardization
timeFrame: 1 year
measure: Secondary endpoints related to outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen (campus Sint-Augustinus)
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Gent
country: Belgium
facility: UZ Gent
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Turnhout
country: Belgium
facility: AZ Turnhout (campus Sint-Elisabeth)
Study officials:
affiliation: Belgian College of Physicians for Radiation Oncology Centers
name: Luigi Moretti, MD, PhD
role: STUDY_CHAIR
References: