ProCaLung: Project on Cancer of the Lung

NCT04726358 | Unknown DMC

• 1 other identifier: 2019-42
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Locally Advanced Lung Carcinoma

Keywords

NSCLC; Radiation therapy; Mediastinal adenopathy; Quality assurance; Delineation; National registry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Secondary endpoints related to standardization

  1 year

• Secondary endpoints related to outcomes

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Belgian Federal Public Service, Food Chain Safety and Environment: collaborator
• Belgian Cancer Registry: collaborator

Study Sites (5)

GZA Ziekenhuizen (campus Sint-Augustinus)

Antwerp, 2610, Belgium

RECRUITING

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

AZ Sint-Maarten

Mechelen, 2800, Belgium

RECRUITING

AZ Turnhout (campus Sint-Elisabeth)

Turnhout, 2300, Belgium

RECRUITING

Study Officials

• Luigi Moretti, MD, PhD

  Belgian College of Physicians for Radiation Oncology Centers

  STUDY CHAIR

Central Study Contacts

Luigi Moretti, MD, PhD

CONTACT

+3225413800; Luigi.moretti@bordet.be

Thomas Descamps, MD

CONTACT

+325413800; Thomas.descamps@bordet.be

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: January 27, 2021
• Study Start: October 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: June 12, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)