Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy (SCOPE)

November 7, 2013 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Recruiting
        • Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery
        • Contact:
        • Principal Investigator:
          • A. Verhagen Verhagen, MD
        • Principal Investigator:
          • T. van Brakel, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OPEN lobectomy
Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.
Procedure: OPEN lobectomy
Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.
Active Comparator: VATS lobectomy
Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.
Procedure: VATS lobectomy
Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.
Other: ROBOT-assisted lobectomy
Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).
Device: ROBOT-assisted lobectomy
Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (EQ5D)
Time Frame: up to12 month
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
Hospital length of stay
Time Frame: day of discharge from hospital after surgery (expected within 2 weeks).
day of discharge from hospital after surgery (expected within 2 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cancer specific quality of life (QLQ C30 and 13)
Time Frame: preoperatively 1 week before surgery and at 3-6 and 12 month
preoperatively 1 week before surgery and at 3-6 and 12 month
number of dissected mediastinal lymphnode stations
Time Frame: day 0 (intraoperatively)
The number of intraoperatively dissected mediastinal lymphnode stations is assessed as a secondary oncologic outcome measure.
day 0 (intraoperatively)
composite endpoint of intra- and postoperative complications
Time Frame: form the day of surgery up to discharege (expected within 2 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

University Medical Center Nijmegen

Investigators

  • Principal Investigator: A. Verhagen, MD, Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery Route 677 Postbus 9101, 6500 HB Nijmegen Tel: + 31 24 361 47 44 Fax: +31 24 354 01 29
  • Principal Investigator: T. van Brakel, MD, PhD, Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery Route 677 Postbus 9101, 6500 HB Nijmegen Tel: + 31 24 361 47 44 Fax: +31 24 354 01 29

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCN_NL40542.091.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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