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Non-small Cell Lung Cancer Stage IPhase 3cVATSNCT02011997

Comparison of cVATS Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

A Phase 3 study testing patients undergo cVATS segmentectomy and Patients undergo cVATS lobectomy in people with Non-small Cell Lung Cancer Stage I and Lung Adenocarcinoma, run by The First Affiliated Hospital of Guangzhou Medical University at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion. Read more about this study

Who is it for?
Ages 20 to 79 years
What is being tested?
patients undergo cVATS segmentectomy and Patients undergo cVATS lobectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
6 sitesChina
Study dates
Dec 2013to Dec 2021
Phase
Phase 3
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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm in maximal diameter, no lymph node metastasis, FEV1%>50% (FEV1: Forced Expiratory Volume in 1 second);
  • Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solid areas < 0.5cm);
  • Follow-up duration last 3 months or more, HRCT (HRCT: high-resolution computed tomography) lesion maximum diameter was measured three times and took the average, meet the criteria of clinical surgical indications;
  • Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or with microinvasion;
  • No prior ipsilateral thoracotomy;
  • No prior anti-neoplastic therapy;
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  • EOCG Performance status 0-2;
  • Sufficient organ functions;
  • Written informed consent.

Who cannot join

  • Active bacterial or fungous infection;
  • Simultaneous or prior (within the past 5 years) other malignant disease;
  • Interstitial pneumonitis, pulmonary fibrosis, or severe COPD (COPD: chronic obstructive pulmonary disease);
  • Abnormal Psychosis;
  • Uncontrollable diabetes mellitus;
  • History of severe cardiovascular disease;
  • Any condition which, in the opinion of the investigator might interfere with the evaluation of the objective.

Trial locations and contacts

6 sites in 1 country.

Jianxing He, MD contact

83062810

drjianxinghe@163.com

6 sites in 1 country

China6 sites

  • China-Japan Friendship hospital

    Beijing

  • Peking University Cancer Hospital

    Beijing

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • Nanfang Hospital

    Guangzhou, Guangdong

  • First Affiliated Hospital Zhejiang University colleague of Medicine

    Hangzhou, Zhejiang

  • Shanghai Chest Hospital

    Shanghai

Other trials in China

About this study

Official title: Comparison of Video-assisted Thoracoscopic Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion

This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.

Read the detailed description

Lobectomy has long been considered the standard procedure for early-stage lung cancer, and minimally invasive techniques have been demonstrated to be associated with superior outcomes compared with lobectomy by thoracotomy. the us of segmentectomy is under investigation for selected patients with small tumors, and the use of minimally invasive strategies is applicable as well.

This nationwide, multicenter, prospective, randomized open phase III study of cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy versus Lobectomy for stage IA non-small cell lung cancer (NSCLC) patients with Lung adenocarcinoma in situ or with microinvasion, is aiming to evaluate the relapse free survival and 5 year overall survival (OS) rate of two types of surgery. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo cVATS lobectomy.
  • Arm II: Patients undergo cVATS segmentectomy.

Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.

Being tested
patients undergo cVATS segmentectomy, Patients undergo cVATS lobectomy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patients undergo cVATS segmentectomyProcedure or surgery

  • Patients undergo cVATS lobectomyProcedure or surgery

Study groups in NCT02011997
Study groupRoleWhat they receive
segmentectomyExperimentalPatients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy
Receives: Procedure: patients undergo cVATS segmentectomy
LobectomyActive comparatorPatients undergo cVATS lobectomy
Receives: Procedure: Patients undergo cVATS lobectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free survival

    Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy.

    Measured: From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years

Secondary outcomes (4)

  1. 5-year survival rate

    Compare the 5-year survival rate of patients undergoing cVATS segmentectomy vs lobectomy

    Measured: participants are followed until death or up to 5 years

  2. postoperative complication

    Compare the postoperative complication rate of patients undergoing cVATS segmentectomy vs lobectomy

    Measured: 0 to 3 months postoperatively

  3. pulmonary function

    to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months postoperatively

    Measured: 6 months after surgery

  4. Quality of Life

    To evaluate the quality of life (QoL) of these patients, as measured by questionnaire of FACT-L (4th edition) and LCSS (Lung Cancer Symptom Scale)

    Measured: 0 to 6 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02011997
Sponsor's protocol ID
FAH-GZU-001
Acronym
cVATS
Status last verified
Dec 2013
First submitted
16 Nov 2013
Last updated
16 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Van Schil PE, Asamura H, Rusch VW, Mitsudomi T, Tsuboi M, Brambilla E, Travis WD. Surgical implications of the new IASLC/ATS/ERS adenocarcinoma classification. Eur Respir J. 2012 Feb;39(2):478-86. doi: 10.1183/09031936.00027511. Epub 2011 Aug 4.

    PubMed 21828029

  • Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995 Sep;60(3):615-22; discussion 622-3. doi: 10.1016/0003-4975(95)00537-u.

    PubMed 7677489

  • Koike T, Togashi K, Shirato T, Sato S, Hirahara H, Sugawara M, Oguma F, Usuda H, Emura I. Limited resection for noninvasive bronchioloalveolar carcinoma diagnosed by intraoperative pathologic examination. Ann Thorac Surg. 2009 Oct;88(4):1106-11. doi: 10.1016/j.athoracsur.2009.06.051.

    PubMed 19766789

  • Yan TD, Black D, Bannon PG, McCaughan BC. Systematic review and meta-analysis of randomized and nonrandomized trials on safety and efficacy of video-assisted thoracic surgery lobectomy for early-stage non-small-cell lung cancer. J Clin Oncol. 2009 May 20;27(15):2553-62. doi: 10.1200/JCO.2008.18.2733. Epub 2009 Mar 16.

    PubMed 19289625

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing patients undergo cVATS segmentectomy and Patients undergo cVATS lobectomy in people with Non-small Cell Lung Cancer Stage I and Lung Adenocarcinoma, run by The First Affiliated Hospital of Guangzhou Medical University at 6 sites in China.

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 9 inclusion and 7 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 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jianxing He, MD (83062810, drjianxinghe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival (time frame: From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02011997, which also lists 4 linked publications.

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 16 Dec 2013.

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