NCT01933828

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 8, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

May 27, 2013

Last Update Submit

November 7, 2013

Conditions

Lung Cancer

Keywords

Lung cancersurgery video-assistedrobotsurgical treatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • Hospital length of stay

    day of discharge from hospital after surgery (expected within 2 weeks).

Secondary Outcomes (3)

  • cancer specific quality of life (QLQ C30 and 13)

    preoperatively 1 week before surgery and at 3-6 and 12 month

  • number of dissected mediastinal lymphnode stations

    day 0 (intraoperatively)

  • composite endpoint of intra- and postoperative complications

    form the day of surgery up to discharege (expected within 2 weeks)

Study Arms (3)

OPEN lobectomy

ACTIVE COMPARATOR

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

Procedure: OPEN lobectomy

VATS lobectomy

ACTIVE COMPARATOR

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

Procedure: VATS lobectomy

ROBOT-assisted lobectomy

OTHER

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

Device: ROBOT-assisted lobectomy

Interventions

OPEN lobectomyPROCEDURE

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

OPEN lobectomy
VATS lobectomyPROCEDURE

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

VATS lobectomy
ROBOT-assisted lobectomyDEVICE

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

ROBOT-assisted lobectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nijmegen, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas J van Brakel, MD, PhD

CONTACT

+ 31 24 361 47 44t.vanbrakel@ctc.umcn.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2013

First Posted

September 2, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 8, 2013

Record last verified: 2013-08

Locations

NL(1)