Locally Advanced Lung CarcinomaProCaLungNCT04726358
ProCaLung: Project on Cancer of the Lung
An observational study of Locally Advanced Lung Carcinoma, run by Jules Bordet Institute at 5 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Lung Carcinoma
- How many people
- 1,000 participants
- Where
- 5 sitesBelgium
- Study dates
- 1 Oct 2021to 1 Mar 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated with thoracic radiotherapy in Belgium for NSCLC with at least one positive mediastinal node.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
GZA Ziekenhuizen (campus Sint-Augustinus)
Antwerp, 2610
- Recruiting
Institut Jules Bordet
Brussels, 1070
- Recruiting
UZ Gent
Ghent, 9000
- Recruiting
AZ Sint-Maarten
Mechelen, 2800
- Recruiting
AZ Turnhout (campus Sint-Elisabeth)
Turnhout, 2300
About this study
Official title: 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.
- Conditions
- Locally Advanced Lung Carcinoma
- Keywords
- NSCLC, Radiation therapy, Mediastinal adenopathy, Quality assurance, Delineation, National registry
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Oct 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Federal Public Service, Food Chain Safety and Environment, Belgian Cancer Registry
- Responsible party
- Sponsor
- Investigators
- Luigi Moretti, MD, PhD, Study chair, Belgian College of Physicians for Radiation Oncology Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726358
- Sponsor's protocol ID
- 2019-42
- Acronym
- ProCaLung
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2020
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProCaLung - Project on Cancer of the Lung : A National Radiotherapy Quality Assurance for Stage III NSCLC
- ClinicalTrials.gov ID
- NCT04726358
- Acronym / sponsor ID
- ProCaLung / 2019-42
- Conditions
- Locally Advanced Lung Carcinoma
- Keywords
- NSCLC, Radiation therapy, Mediastinal adenopathy, Quality assurance, Delineation, National registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Belgian Federal Public Service, Food Chain Safety and Environment, Belgian Cancer Registry
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with thoracic radiotherapy in Belgium for NSCLC with at least one positive mediastinal node.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
descriptive statistics for quality assurance (no sample size needed)
Time frame: 1 year
* 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.
descriptive statistics for QA (no sample size needed)
Time frame: 2 years
* 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 secondary outcomes
Secondary endpoints related to standardization
Time frame: 1 year
Secondary endpoints related to outcomes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Moretti, MD, PhD study chair
Belgian College of Physicians for Radiation Oncology Centers
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Lung Carcinoma, run by Jules Bordet Institute at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Moretti, MD, PhD (+3225413800, Luigi.moretti@bordet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descriptive statistics for quality assurance (no sample size needed) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.