- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04726358
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
Conditions
Study Type
Enrollment (Estimated)
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
-
-
-
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
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
descriptive statistics for quality assurance (no sample size needed)
Time Frame: 1 year
|
|
1 year
|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary endpoints related to standardization
Time Frame: 1 year
|
|
1 year
|
Secondary endpoints related to outcomes
Time Frame: 2 years
|
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Luigi Moretti, MD, PhD, Belgian College of Physicians for Radiation Oncology Centers
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Locally Advanced Lung Carcinoma
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Locally Advanced Bladder Urothelial Carcinoma | Locally Advanced Renal Pelvis Urothelial... and other conditionsUnited States
-
Emory UniversityAstex Pharmaceuticals, Inc.RecruitingHead and Neck Carcinoma of Unknown Primary | Locally Advanced Head and Neck Squamous Cell Carcinoma | Locally Advanced Hypopharyngeal Squamous Cell Carcinoma | Locally Advanced Laryngeal Squamous Cell Carcinoma | Locally Advanced Nasopharyngeal Squamous Cell Carcinoma | Locally Advanced Oropharyngeal...United States
-
Memorial Sloan Kettering Cancer CenterRecruitingSkin Cancer | Squamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Locally Advanced Skin Squamous Cell Carcinoma | Locally Advanced Cutaneous Squamous Cell Carcinoma | Locally Advanced Squamous Cell Carcinoma | Locally Advanced Squamous Cell Carcinoma of the SkinUnited States
-
Mayo ClinicRecruitingMetastatic Lung Non-Small Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Resectable Lung Non-Small Cell Carcinoma | Metastatic Malignant Solid Neoplasm | Metastatic Bladder Urothelial Carcinoma | Metastatic Colorectal Carcinoma | Metastatic Triple-Negative Breast Carcinoma | Locally... and other conditionsUnited States
-
Assiut UniversityNot yet recruitingLocally Advanced Cervical Carcinoma
-
AmgenNo longer availableNon Small-cell Lung Cancer | Locally Advanced Unresectable NSCLC | Locally Advanced Metastatic NSCLCUnited States, Taiwan, Israel, Saudi Arabia, Brazil, Argentina
-
Shanghai Runshi Pharmaceutical Technology Co., LtdJilin Provincial Tumor HospitalRecruitingLocally Advanced Unresectable CarcinomaChina
-
National Cancer Institute (NCI)Not yet recruitingMetastatic Melanoma | Locally Advanced Melanoma | Metastatic Alveolar Soft Part Sarcoma | Metastatic Non Small Cell Lung Cancer | Metastatic Hepatocellular Carcinoma | Locally Advanced Hepatocellular Carcinoma | Metastatic Small Cell Lung Cancer | Locally Advanced Non Small Cell Lung Cancer | Locally... and other conditionsUnited States
-
Xuanzhu Biopharmaceutical Co., Ltd.RecruitingLocally Advanced or Metastatic Solid Tumors | Locally Advanced or Metastatic Non-small Cell Lung CancerChina
-
PfizerRecruitingLocally Advanced or Metastatic ER+ HER2- Breast Cancer | Locally Advanced or Metastatic Castration-resistant Prostate Cancer | Locally Advanced or Metastatic Non-small Cell Lung CancerUnited States, China, Australia, Korea, Republic of, Japan