Non-small Cell Lung CancerNCT03451526
A Study to Explore Prognoses of the Patients With N2 Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Tang-Du Hospital at 10 sites in China.
Trial summary
The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 2,929 participants
- Where
- 10 sitesChina
- Study dates
- 1 Dec 2017to 30 Mar 2018
- 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: Pathologically diagnosed Chinese patients with N2 non-small cell lung cancer who received radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies
Who may be able to join
- Patients with radical resection of lung cancer enrolled from 2014 to 2019;
- Pathologically diagnosed patients with non-small cell lung cancer;
- Patients with age > 18 years old;
- Patients who did not receive chest surgeries before hospitalization;
- Patients with N2 lymph nodes (+) after surgeries;
- Patients who received lymphadenectomy for one group or more groups of lymph nodes;
Who cannot join
- Patients with second primary tumors or multiple primary tumors;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
China PLA General Hospital
Beijing, Beijing Municipality, 100853
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, 610041
First Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310003
Jiangsu cancer hospital
Nanjing, Jiangsu, 210009
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200003
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 710000
Henan cancer hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Multi-centre Real-world Non-interventional Observational Study to Compare Prognoses of the Chinese Patients With N2 Non-small Cell Lung Cancer Who Received Adjuvant Chemotherapies and Perioperative Chemotherapies After Surgeries
The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer
Read the detailed description
The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Surgeries
- Keywords
- Chinese, real-world evidences, NSCLC, surgeries
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeriesProcedure or surgery
Also called Adjuvant chemotherapies or perioperative chemotherapies
Surgeries plus adjuvant chemotherapies or perioperative chemotherapies
| Study group | Role | What they receive |
|---|---|---|
| Surgeries+adjuvant chemotherapies | Patients who received radical resection of lung cancer + adjuvant chemotherapies Receives: Procedure: Surgeries | |
| Perioperative chemotherapies | Patients who received perioperative chemotherapies Receives: Procedure: Surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 2014 - 2017
Secondary outcomes (1)
Disease-free survival
Disease-free survival
Measured: 2014 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,929 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, lixiaofei, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451526
- Sponsor's protocol ID
- W-TONG04
- Status last verified
- May 2018
- First submitted
- 2 Feb 2018
- Last updated
- 21 May 2018
- 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 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Real-world Non-interventional Observational Study to Compare Prognoses of the Chinese Patients With N2 Non-small Cell Lung Cancer Who Received Adjuvant Chemotherapies and Perioperative Chemotherapies After Surgeries
- ClinicalTrials.gov ID
- NCT03451526
- Acronym / sponsor ID
- W-TONG04
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Chinese, real-world evidences, NSCLC, surgeries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,929 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 1 Mar 2018 (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.
The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer
Detailed description
The trial is a multi-centre real-world non-interventional observational study. The Chinese patients with N2 non-small cell lung cancer enrolled from 2014 to 2017 who received radical resections of lung cancer and adjuvant chemotherapies will be included in the study and the study data on patient demographic/tumor biological characteristics and clinical treatment will be collected to evaluate compare effectiveness of radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies after surgeries.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeries+adjuvant chemotherapies | – | Procedure: SurgeriesPatients who received radical resection of lung cancer + adjuvant chemotherapies |
| Perioperative chemotherapies | – | Procedure: SurgeriesPatients who received perioperative chemotherapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically diagnosed Chinese patients with N2 non-small cell lung cancer who received radical resection of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies
Key inclusion criteria (6 listed)
- Patients with radical resection of lung cancer enrolled from 2014 to 2019;
- Pathologically diagnosed patients with non-small cell lung cancer;
- Patients with age > 18 years old;
- Patients who did not receive chest surgeries before hospitalization;
- Patients with N2 lymph nodes (+) after surgeries;
Key exclusion criteria (1 listed)
- Patients with second primary tumors or multiple primary tumors;
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 |
|---|---|---|
| SurgeriesAlso: Adjuvant chemotherapies or perioperative chemotherapiesSurgeries plus adjuvant chemotherapies or perioperative chemotherapies | Procedure or surgery | Perioperative chemotherapies, Surgeries+adjuvant chemotherapies |
Primary outcome
Overall survival
Time frame: 2014 - 2017
Overall survival
1 secondary outcome
Disease-free survival
Time frame: 2014 - 2017
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 21 May 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Tang-Du Hospital at 10 sites in China.
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 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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?
Overall survival (time frame: 2014 - 2017). 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 21 May 2018.