Lung CancerPTOP-RTNCT04545658
Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy
An observational study of Lung Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
(Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2020to 31 Jul 2020
- 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
- Adult, Older adult
Study population: Stage I, II, III lung cancer patients treated with (chemo)-radiotherapy
Who may be able to join
- Patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy
Who cannot join
- Incomplete treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy for Lung Cancer Management
(Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Acute Pulmonary Toxicity
The model's performance will be evaluated based on the observed rate of Acute Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).
Measured: Up to 6 months
Prediction of Late Pulmonary Toxicity
The model's performance will be evaluated based on the observed rate of Late Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).
Measured: Between 6 months and 2 years after radiotherapy
Prediction of Acute Oesophageal Toxicity
The model's performance will be evaluated based on the observed rate of Acute Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).
Measured: Up to 6 months
Prediction of Late Oesophageal Toxicity
The model's performance will be evaluated based on the observed rate of Late Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).
Measured: Between 6 months and 2 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start16 Jul 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545658
- Sponsor's protocol ID
- PTOP-RT (29BRC20.0154)
- Acronym
- PTOP-RT
- Status last verified
- Jul 2020
- First submitted
- 10 Aug 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy for Lung Cancer Management
- ClinicalTrials.gov ID
- NCT04545658
- Acronym / sponsor ID
- PTOP-RT / PTOP-RT (29BRC20.0154)
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Sep 2020 (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.
(Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stage I, II, III lung cancer patients treated with (chemo)-radiotherapy
Key inclusion criteria (1 listed)
- Patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy
Key exclusion criteria (1 listed)
- Incomplete treatment
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
Prediction of Acute Pulmonary Toxicity
Time frame: Up to 6 months
The model's performance will be evaluated based on the observed rate of Acute Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).
Prediction of Late Pulmonary Toxicity
Time frame: Between 6 months and 2 years after radiotherapy
The model's performance will be evaluated based on the observed rate of Late Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy).
Prediction of Acute Oesophageal Toxicity
Time frame: Up to 6 months
The model's performance will be evaluated based on the observed rate of Acute Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).
Prediction of Late Oesophageal Toxicity
Time frame: Between 6 months and 2 years after radiotherapy
The model's performance will be evaluated based on the observed rate of Late Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University Hospital, Brest at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Acute Pulmonary Toxicity (time frame: Up to 6 months). The study lists 4 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 11 Sep 2020.