Advanced Non-small-cell Lung CancerNCT04455984
Multimodality Treatment Including Curative Resection of Advanced NSCLC
An observational study of Advanced Non-small-cell Lung Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study retrospectively evaluates clinical parameters and outcome of patients with advanced stage non-small cell lung cancer treated with neoadjuvant therapy followed by curative-intent surgery at the Divison of Thoracic Surgery at the Medical University of Vienna Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Non-small-cell Lung Cancer
- What is being tested?
- Date collection
- How many people
- 190 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2017to 1 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with non-small-cell lung cancer, who received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention at the Devision of Thoracic Surgery, Medical University.
Who may be able to join
- Patients with advanced NSCLC and multimodality treatment including curative-intent resection
Who cannot join
- Patients with early stage NSCLC
- Patients with advanced NSCLC without multimodality treatment
- Patients without curative resection
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Katharina Sinn, MD
About this study
Official title: Multimodality Treatment Including Curative Resection of Advanced Stage Non-small Cell Lung Cancer - an Explorative, Retrospective Pilot Study
This study retrospectively evaluates clinical parameters and outcome of patients with advanced stage non-small cell lung cancer treated with neoadjuvant therapy followed by curative-intent surgery at the Divison of Thoracic Surgery at the Medical University of Vienna
Read the detailed description
This study will be undertaken as a retrospective cohort study at Devision of Thoracic Surgery, Medical University of Vienna. All patients with non-small-cell lung cancer, who received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention at the Devision of Thoracic Surgery, Medical University, will be included. The aim of this study is to evaluate peri- and postoperative clinical parameters and short- and long-term outcomes in patients.
- Conditions
- Advanced Non-small-cell Lung Cancer
- Being tested
- Date collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date collectionOther
Retrospective data analysis
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiotherapy | Patients with advanced NSCLC treated with neoadjuvant platinum-based chemoradiotherapy followed by curative-intent surgery Receives: Other: Date collection | |
| Neoadjuvant chemotherapy | Patients with advanced NSCLC treated with neoadjuvant platinum-based chemotherapy followed by curative-intent surgery Receives: Other: Date collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
- Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery
- Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery
- Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 May 2017
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Sinn, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455984
- Sponsor's protocol ID
- 193132122
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Treatment Including Curative Resection of Advanced Stage Non-small Cell Lung Cancer - an Explorative, Retrospective Pilot Study
- ClinicalTrials.gov ID
- NCT04455984
- Acronym / sponsor ID
- 193132122
- Conditions
- Advanced Non-small-cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 2 Jul 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.
This study retrospectively evaluates clinical parameters and outcome of patients with advanced stage non-small cell lung cancer treated with neoadjuvant therapy followed by curative-intent surgery at the Divison of Thoracic Surgery at the Medical University of Vienna
Detailed description
This study will be undertaken as a retrospective cohort study at Devision of Thoracic Surgery, Medical University of Vienna. All patients with non-small-cell lung cancer, who received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention at the Devision of Thoracic Surgery, Medical University, will be included. The aim of this study is to evaluate peri- and postoperative clinical parameters and short- and long-term outcomes in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiotherapy | – | Other: Date collectionPatients with advanced NSCLC treated with neoadjuvant platinum-based chemoradiotherapy followed by curative-intent surgery |
| Neoadjuvant chemotherapy | – | Other: Date collectionPatients with advanced NSCLC treated with neoadjuvant platinum-based chemotherapy followed by curative-intent surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with non-small-cell lung cancer, who received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention at the Devision of Thoracic Surgery, Medical University.
Key inclusion criteria (1 listed)
- Patients with advanced NSCLC and multimodality treatment including curative-intent resection
Key exclusion criteria (3 listed)
- Patients with early stage NSCLC
- Patients with advanced NSCLC without multimodality treatment
- Patients without curative resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Date collectionRetrospective data analysis | Other | Neoadjuvant chemoradiotherapy, Neoadjuvant chemotherapy |
Primary outcome
Overall survival
Time frame: 18 years
* Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery * Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery * Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- 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.
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 Advanced Non-small-cell Lung Cancer, run by Medical University of Vienna at 1 site in Austria.
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 3 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 7 Jul 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 Austria. 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 Katharina Sinn, MD (004314040056440, katharina.sinn@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 18 years). 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 7 Jul 2020.