Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy

Trial Title: Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy

NCT ID: NCT01933828

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Lung cancer
surgery video-assisted
robot
surgical treatment

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Investigator)

Intervention:

Intervention type: Procedure
Intervention name: OPEN lobectomy
Description: Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.
Arm group label: OPEN lobectomy

Intervention type: Procedure
Intervention name: VATS lobectomy
Description: Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.
Arm group label: VATS lobectomy

Intervention type: Device
Intervention name: ROBOT-assisted lobectomy
Description: Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).
Arm group label: ROBOT-assisted lobectomy

Summary: In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open procedure by thoracotomy for patients with early stage lung cancer, but randomized evidence for superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation yet. The objective of this study is to assess the benefits of VATS- over open lobectomy regarding quality of life and costs in a prospective randomized controlled multicenter trial. All patients meeting the inclusion criteria that are not randomized will be included in a prospective Cohort.

Detailed description: Rationale: Surgical lobectomy is the treatment of choice for patients with early stage lung cancer. In some centres, video-assisted thoracic surgery (VATS) lobectomy is preferred, where other centres hold on to the conventional open lobectomy via a thoracotomy. Although several studies have demonstrated fewer postoperative complications and shorter hospital length of stay for the VATS procedure, others have reported concerns regarding oncologic equivalence, mainly based on incomplete lymph node staging. Convincing randomized evidence from the literature is lacking. The aim of this randomized multicentre study is to compare quality of life, oncologic endpoints and cost-effectiveness between VATS- and open (thoracotomy) lobectomy. Objective: To compare quality of life, cost-effectiveness and number of dissected mediastinal lymph nodes between open,VATS and ROBOT-assisted lobectomy. Study design: A prospective multi-centre randomized trial with a prospective registry arm Study population: Adult patients of either gender, selected by the pulmonary oncological multidisciplinary team to undergo surgical lobectomy for early-stage lung carcinoma. Intervention: One group is assigned to the open procedure: posterolateral thoracotomy for lobectomy with mediastinal lymph node dissection. The other group is assigned to the VATS procedure: thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection. All patients that do meet the inclusion criteria but are not participating in the randomized trial can be included in the prospective Cohort arm of the study evaluating clinical assignment to OPEN- VATS or ROBOT-assisted lobectomy. Main study parameters/endpoints: Primary endpoints are postoperative quality of life, and hospital length of stay. Secondary endpoints include cancer specific quality of life, number of dissected mediastinal lymph nodes and stations, procedural complication rates, pulmonary function, overall costs and survival. Centres participating in this study currently perform the open- and VATS and/or ROBOT-assisted lobectomy in daily clinical practice.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Non-small cell lung carcinoma, pathologically confirmed or strong suspicion based on imaging. - T1 or T2a (≤ 5 cm) on computer tomography (CT). - Primary aim is lobectomy. - Tumor not in close relation to the hilar structures (bronchus,vessels)based on CT. - Clinically staged N0 (no regional lymph node metastasis) or N1 (metastasis to ipsilateral, hilar, interlobar- and/or intrapulmonary lymph nodes), M0 (no distant metastasis) after clinical staging according to the current Dutch guideline (may 2011). Exclusion Criteria: - T2b, T3 or T4 tumor (7th guideline TNM classification NSCLC). - Mediastinal lymph node metastasis (N2, N3). - Distant metastasis (M1). - Previous thoracic surgery on same side. - Pneumonectomy as primary aim.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery

Address:
City: Nijmegen
Zip: 6500 HB
Country: Netherlands

Status: Recruiting

Contact:
Last name: A. Verhagen, MD

Phone: + 31 24 361 47 44
Email: a.verhagen@ctc.umcn.nl

Investigator:
Last name: A. Verhagen Verhagen, MD
Email: Principal Investigator

Investigator:
Last name: T. van Brakel, MD, PhD
Email: Principal Investigator

Start date: June 2013

Completion date: June 2015

Lead sponsor:
Agency: Radboud University Medical Center
Agency class: Other

Collaborator:
Agency: University Medical Center Nijmegen
Agency class: Other

Source: Radboud University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01933828