NCT06028412Enrolling by invitation
Comparison of Sublobar and Lobectomy in Small (2 Cm or Less 0.5<CTR<1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study
Comparison of Segmentectomy and Lobectomy in Small (2 Cm or Less 0.5<CTR<1) Non-small Cell Lung Cancer: a Prospective, Multicenter Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The early NSCLC(Non-small cell lung cancer) patients with partial solid nodules mainly composed of solid components, whose maximum tumor diameter was ≤ 2.0cm and 0.5\<CTR(Consolidation tumor ratio)\<1, as indicated by preoperative thin slice CT, were selected as the study objects. The short-term and long-term effects of segmental resection and lobectomy under Thoracoscopy were compared to provide high-level evidence for the selection of surgical treatment methods for early NSCLC.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 29 Aug 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Xiaolong Yan, Dr.
- Diseases
- Lung cancer
- NCT number
- NCT06028412
What you commit to
- Study type: Interventional
- Planned participants: 660
- From 1 Jan 2023 to the primary completion date, 31 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
- Those who have received anti-tumor treatment (radiotherapy, chemotherapy, Targeted therapy, immunotherapy) before surgery;
- Previous history of lung surgery;
- Those who undergo thoracotomy or change the surgical plan due to various reasons during surgery;
- Individuals who have conducted other clinical trials in the three months prior to enrollment.
- Secondary exclusion criteria:
Other illness
- Hypertension and diabetes difficult to control;
- Severe mental illness;
- Individuals with a history of severe heart disease, heart failure, myocardial infarction, or angina within the past 6 months;
- Active bacterial or fungal infections that are difficult to control;
- Postoperative pathological results of non NSCLC malignant tumors;
- Non small cell lung cancer confirmed histologically during operation, but with malignant Pleural effusion and pleural dissemination
Other
- Initial exclusion criteria:
- Pregnant or lactating women;
- Interstitial pneumonia, Pulmonary fibrosis or severe Emphysema;
- The postoperative pathological result was Benign tumor;
Who the study is looking for
- nitial inclusion criteria:
- Age 18-75 years old, regardless of gender;
- ECOG PS score 0-1 points (Attachment 3.4);
- Preoperative clinical staging for patients with suspected NSCLC lesions in Phase I (according to AJCC Eighth Edition staging standards, Attachment 3.5);
- Thin slice CT indicates that the maximum tumor diameter is ≤ 2.0cm;
- Pre operative CT prompts 0.5\<CTR\<1.0;
- Good lung function (FEV1\>1.5 L or FEV1% ≥ 60%), able to tolerate both segmental resection and lobectomy;
- The number of pulmonary nodules that need to be processed is ≤ 3, and the nodules are located in the same side of the lung;
- Those who voluntarily sign the research informed consent form can comply with the research visit plan and other protocol requirements.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Air Force Medical University University of PLA Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.