NCT04944563Recruiting
Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field
Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study
Source: ClinicalTrials.gov · Last updated 5 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1120 (estimated)
- First submitted
- 17 Jun 2021
- Start date
- 20 Jul 2021
- Primary completion date
- 1 Dec 2029
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Lung cancer
- NCT number
- NCT04944563
What you commit to
- Study type: Interventional
- Planned participants: 1120
- From 20 Jul 2021 to the primary completion date, 1 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
- The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
Other illness
- A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
- A serious mental illness;
- Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
- With the history of cerebral infarction or cerebral hemorrhage within 6 months;
- With the history of sustained systemic corticosteroid therapy within 1 month;
Other
- The tumor nodule is located in right middle lobe;
- Pregnant and lactating women;
- Other unsuitable situations;
Who the study is looking for
- Patient aged 18-75 years old;
- 6 mm ≤ tumor size ≤ 20 mm;
- 0.25 \< CTR \< 1;
- Center of tumor located in the middle third of the lung field;
- ECOG score of 0,1 or 2;
- Lung function (FEV1 ≥ 1 L and ≥ 70%);
- Both lung segmentectomy and lobectomy could achieve R0 resection;
- No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
- No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
- Single tumor nodule or the concomitant nodule \< microinvasive tumor;
- Written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.