Lung CancerSCOPENCT01933828
Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy
A study testing OPEN lobectomy, VATS lobectomy and ROBOT-assisted lobectomy in people with Lung Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- OPEN lobectomy, VATS lobectomy and ROBOT-assisted lobectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Center, Department of Cardio-thoracic Surgery
Nijmegen, 6500 HB
A. Verhagen, MD, + 31 24 361 47 44, a.verhagen@ctc.umcn.nl
A. Verhagen Verhagen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- OPEN lobectomy, VATS lobectomy, ROBOT-assisted lobectomy
- Keywords
- Lung cancer, surgery video-assisted, robot, surgical treatment
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPEN lobectomyProcedure or surgery
Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.
VATS lobectomyProcedure or surgery
Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.
ROBOT-assisted lobectomyDevice
Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).
| Study group | Role | What they receive |
|---|---|---|
| OPEN lobectomy | Active comparator | Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading. Receives: Procedure: OPEN lobectomy |
| VATS lobectomy | Active comparator | Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading. Receives: Procedure: VATS lobectomy |
| ROBOT-assisted lobectomy | Other | Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort). Receives: Device: ROBOT-assisted lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to12 month
Hospital length of stay
Measured: day of discharge from hospital after surgery (expected within 2 weeks).
Secondary outcomes (3)
cancer specific quality of life (QLQ C30 and 13)
Measured: preoperatively 1 week before surgery and at 3-6 and 12 month
number of dissected mediastinal lymphnode stations
The number of intraoperatively dissected mediastinal lymphnode stations is assessed as a secondary oncologic outcome measure.
Measured: day 0 (intraoperatively)
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.
Measured: form the day of surgery up to discharege (expected within 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Nijmegen
- Responsible party
- Sponsor
- Investigators
- A. Verhagen, MD, 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 29T. van Brakel, MD, PhD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933828
- Sponsor's protocol ID
- UMCN_NL40542.091.12
- Acronym
- SCOPE
- Status last verified
- Aug 2013
- First submitted
- 27 May 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- thoracoSCopic Versus OPen Lobectomy for Early Stage Lung Cancer: a Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT01933828
- Acronym / sponsor ID
- SCOPE / UMCN_NL40542.091.12
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, surgery video-assisted, robot, surgical treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- University Medical Center Nijmegen
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPEN lobectomy | Active comparator | Procedure: OPEN lobectomyLobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading. |
| VATS lobectomy | Active comparator | Procedure: VATS lobectomyThoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading. |
| ROBOT-assisted lobectomy | Other | Device: ROBOT-assisted lobectomyRobot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPEN lobectomyLobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading. | Procedure or surgery | OPEN lobectomy |
| VATS lobectomyThoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading. | Procedure or surgery | VATS lobectomy |
| ROBOT-assisted lobectomyRobot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort). | Device | ROBOT-assisted lobectomy |
Primary outcome
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.
Hospital length of stay
Time frame: day of discharge from hospital after surgery (expected within 2 weeks).
3 secondary outcomes
cancer specific quality of life (QLQ C30 and 13)
Time frame: preoperatively 1 week before surgery and at 3-6 and 12 month
number of dissected mediastinal lymphnode stations
Time frame: day 0 (intraoperatively)
composite endpoint of intra- and postoperative complications
Time frame: form the day of surgery up to discharege (expected within 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Verhagen, MD 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 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPEN lobectomy, VATS lobectomy and ROBOT-assisted lobectomy in people with Lung Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas J van Brakel, MD, PhD (+ 31 24 361 47 44, t.vanbrakel@ctc.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (EQ5D) (time frame: up to12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.