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Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy

NCT ID: NCT01933828

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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Lung cancer surgery video-assisted robot surgical treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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OPEN lobectomy

Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.

Group Type ACTIVE_COMPARATOR

OPEN lobectomy

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

VATS lobectomy

Intervention Type PROCEDURE

Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.

ROBOT-assisted lobectomy

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

Group Type OTHER

ROBOT-assisted lobectomy

Intervention Type DEVICE

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

Interventions

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OPEN lobectomy

Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.

Intervention Type PROCEDURE

VATS lobectomy

Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.

Intervention Type PROCEDURE

ROBOT-assisted lobectomy

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Nijmegen

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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A. Verhagen, MD

Role: PRINCIPAL_INVESTIGATOR

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

T. van Brakel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Thomas J van Brakel, MD, PhD

Role: CONTACT

Phone: + 31 24 361 47 44

Email: [email protected]

Facility Contacts

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A. Verhagen, MD

Role: primary

Other Identifiers

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UMCN_NL40542.091.12

Identifier Type: -

Identifier Source: org_study_id