Clinical trial NCT03786003: ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007)
Official title: Lobectomy for Clincial Stage T1N0M0 Solid NSCLC by VATS Versus Thoracotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Video-Assisted Thoracic Surgery
Thoracotomy
Early-stage NSCLC
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 1086
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of this study is to determine video-assisted thoracoscopic surgery is non-inferior to thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC.

Detailed description: It is a randomized clinical trial comparing video-assisted thoracoscopic surgery (VATS) with thoracotomy for solid clinical stage T1N0M0 NSCLC. The primary objective of the study is to determine that VATS is non-inferior to thoracotomy in terms of disease-free survival (DFS). Secondary objectives are to compare VATS and thoracotomy for overall survival (OS), perioperative complications, pain levels and quality of life.

Although there are numerous retrospective studies have indicated feasibility and effectiveness of VATS, no data has been reported from those prospective and randomized clinical trials with prognostic indicators as the primary objective. Whether VATS is non-inferior to thoracotomy in terms of survival is still unclear. Therefore, we design this trial by recruiting patients in clinical stage T1N0M0 with solid mass on computed tomography (CT). To determine the clinical stage, CT scans will be performed routinely and PET-CT/EBUS-TBNA/mediastinoscopy will be conducted in patients with suspected positive mediastinum lymph node or distant metastases. Detailed inclusion criteria include clinical stage T1N0M0 and surgical resectable, solid appearance on CT, age 18 to 75 year and signed informed consent. Exclusion criteria includes not NSCLC in pathologic analysis, no lobectomy or sublobar resection, history of other malignant tumors within 5 years, history of thoracic surgery or unsuitable for VATS and previous radiation or chemotherapy.

In our previous data, the 3-year DFS for cT1N0M0 patients with solid mass who were subjected to thoracotomy (lobectomy or sublobar resection) was 77.9%. If the 3-year DFS of VATS arm is not less than 70.9%, the VATS arm will be regarded to be non-inferior to thoracotomy. A sample size of at least 1086 participants is required for performance equal to 80%, α-level equal to 0.025, 1:1 recruitment and considering a dropout rate of 10%. Participants will be randomly assigned to either group using a random table.

Lobectomy or sublobar resection will be conducted by standard procedures at the discretion of the surgeon. Each participating surgeon will be evaluated by the trial committee to ensure proper surgical technique. If the VATS is diverted to thoracotomy intraoperartively, the reason will be recorded, and the cause will still be analyzed in an intention-to-treat analysis. Patients will be follow-up every 6 months to 3 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Clinical stage T1N0M0 and surgical resectable.
* Solid appearance on computed tomography scan.
* Age 18 to 75 year.
* Signed the informed consent form.

Exclusion Criteria:

* Not NSCLC in pathological analysis.
* Not lobectomy or sublobar resection.
* History of other malignant tumors within 5 years.
* History of thoracic surgery or unsuitable for VATS.
* Previous radiation or chemotherapy.

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years after the surgery
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years after the surgery
measure: Rate of patients with perioperative complication
timeFrame: 1 month after surgery
measure: Pain degree and quality of life
timeFrame: 1 years after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Shanghai Cancer Center
name: Shanghai Cancer Center Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: