Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy

Lung Cancer Clinical Trial

— SCOPE  

Official title:

thoracoSCopic Versus OPen Lobectomy for Early Stage Lung Cancer: a Randomized Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01933828
• Other study ID #: UMCN_NL40542.091.12
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2013
• Last updated: November 7, 2013
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2013
• Source: Radboud University
• Contact: Thomas J van Brakel, MD, PhD
• Phone: + 31 24 361 47 44
• Email: t.vanbrakel[@]ctc.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• OPEN lobectomy
Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.
• VATS lobectomy
Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.

Device:
• ROBOT-assisted lobectomy
Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (EQ5D)	Primary endpoints include Quality of life assessed by EQ5D for VATS versus open lobectomy in patients with early stage non small cell lung carcinoma.	up to12 month	No
Primary	Hospital length of stay		day of discharge from hospital after surgery (expected within 2 weeks).	No
Secondary	cancer specific quality of life (QLQ C30 and 13)		preoperatively 1 week before surgery and at 3-6 and 12 month	Yes
Secondary	number of dissected mediastinal lymphnode stations	The number of intraoperatively dissected mediastinal lymphnode stations is assessed as a secondary oncologic outcome measure.	day 0 (intraoperatively)	No
Secondary	composite endpoint of intra- and postoperative complications	This secondary composite endpoints include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function.	form the day of surgery up to discharege (expected within 2 weeks)	Yes