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Lobectomy for NSCLC by VATS Versus Thoracotomy

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ClinicalTrials.gov Identifier: NCT03786003
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Haiquan Chen, Fudan University

Brief Summary:
The goal of this study is to compare the long-term prognosis between VATS and thoracotomy for lobectomy in consolidation-predominant part-solid early stage NSCLC.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Procedure: VATS Procedure: Thoracotomy Not Applicable

Detailed Description:

It is a randomized clinical trial comparing VATS with thoracotomy for consolidation-predominant early stage NSCLC. The primary objective of this study is to determine VATS is non-inferior to thoracotomy with respect to DFS.

To our opinion, NSCLC at very early stages could not objectively reflect the long-term advantage of VATS, while VATS is not a reasonable choice for late NSCLC. As a result, we design this trial by recruiting patients whose stage is cT1N0-1M0 and the lesion is consolidation-predominant. To determine the clinical stages, CT scan would be performed and PET-CT/EBUS-TBNA/mediastinoscopy would be conducted for those who are suspected to have mediastinum lymph node metastases or distant metastases. The detailed inclusion criteria includes tumor ≤ 3cm; Mediastinum lymph nodes diameter ≤ 1 cm on computed tomography (CT) scan, or a PET scan showing no uptake / a negative mediastinoscopy / a negative " EBUS-TBNA " following mediastinal lymph nodes diameter > 1 cm on CT scan; No distant metastasis; Solid tumor that C/T ratio =1, or part-solid tumor that 0.5 ≤ C/T ratio < 1 and diameter ≥ 1.5cm on CT scan. Specially, the lymph node whose diameter is larger than 1 centimeter in the lung field is considered as stage N1.

In previous statistics of our center, the 5-year DFS of this subgroup patients by performing thoracotomy was 77.52%. If the 5-year DFS does not differ by more than 7%, the two arms will be regarded to be equivalent. Calculated by PASS software, the sample size of patients to be enrolled in the two arms is estimated as 948 cases. The benign cases diagnosed after operation would not be included in analysis according to modified intention-to-treat principle. Considering a 10% benign diseases may be diagnosed, the sample size is adjusted to 1053 cases and the number of event (relapse or death due to tumor) is estimated to be 251 cases.

Patients were divided into two groups by the random table method. The random table has been generated by PASS software with Efron's Biased Coin (p = 0.67) algorithm. 527 cases have been allocated into either group.

The lobectomy and mediastinal lymph node dissection by VATS or thoracotomy would be conducted by standard procedure. Each participating doctor would be evaluated by the trial management committee to ensure proper surgical technique. If the VATS were transferred to thoracotomy, the cause would be recorded and the prognosis result would be still analyzed as the VATS group. Patients would be follow-up by every 6 months after surgery and examination would be conducted routinely.

The interim analysis is set at 5-year after the trial begin and at the timing that 50% events occurred (126 events). If either side of the two arms is determined superior to the other side and the imbalance was confirmed after evaluation, the study would be permanently closed to new patient enrollment and a primary outcome would be published. The follow-up of recruited patients would continue according to the study protocol.

The final analysis would be performed as the follow-up period reach 5 years. The main outcome is DFS at 5 years post surgery. The secondary outcome measures include OS at 5 years post surgery, degree of pain evaluated by NRS and rate of patients with perioperative complication.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1053 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lobectomy for Consolidation-predominant Early Stage NSCLC by VATS Versus Thoracotomy
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2029

Arm Intervention/treatment
Experimental: VATS
Video-assisted thoracoscopic surgery
Procedure: VATS
Standard video assisted thoracic surgery, no use of rib-spreader.

Active Comparator: Thoracotomy
Open surgery
Procedure: Thoracotomy
Standard thoracotomy




Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: Five years after the surgery ]
    Disease-free survival means the period after surgery when no disease can be detected.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Five years after the surgery ]
    Overall survival means the period after surgery when a patient doesn't die directly from that disease or from an unrelated cause.

  2. Degree of pain evaluated by NRS (Numeric rating scale) [ Time Frame: The two days after surgery and the four weeks after discharge ]
    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 point represents no Pain. 1-3 point represents mild pain (nagging, annoying, interfering little with ADLs (activities of daily living)). 4-6 point represents moderate Pain (interferes significantly with ADLs). 7-10 point represents severe Pain (disabling; unable to perform ADLs). The degree of postoperative chest pain would be recorded at 2 days after surgery by a doctor and 4 weeks after discharge by a phone inquiry.

  3. Rate of patients with perioperative complication [ Time Frame: The one month after surgery ]
    The perioperative complication includes wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc within a month after surgery.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologically confirmed primary NSCLC;
  • Tumor ≤ 3cm. Mediastinum lymph nodes diameter ≤ 1 cm on computed tomography (CT) scan, or a PET scan showing no uptake / a negative mediastinoscopy / a negative " EBUS-TBNA " following mediastinal lymph nodes diameter > 1 cm on CT scan; No distant metastasis; (cT1N0-1M0)
  • Solid tumor that C/T ratio =1, or part-solid tumor that 0.5 ≤ C/T ratio < 1 and diameter ≥ 1.5cm on CT scan
  • Suitable for lobectomy by both VATS or thoracotomy in preoperative evaluation;
  • ECOG performance status of 0 or 1;
  • Age ≤ 75 years old and ≥18 years old;
  • Patients who have signed the informed consent form.

Exclusion Criteria:

  • Patients with contraindication for surgery;
  • Patients who had history of thoracotomy and radiation for thoracic region;
  • Patients who had history of other malignant tumors within 5 years;
  • Pregnancy or lactation female patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786003


Contacts
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Contact: Haoxuan Wu, M.D. 86-13901770461 haoxuanwu@hotmail.com
Contact: Haiquan Chen, Ph.D

Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Shanghai Cancer Center Chen, Ph.D Shanghai Cancer Center

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Responsible Party: Haiquan Chen, Director, Fudan University
ClinicalTrials.gov Identifier: NCT03786003     History of Changes
Other Study ID Numbers: LNVT
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Every 3 months after the study begin.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haiquan Chen, Fudan University:
Video-Assisted Thoracic Surgery
Thoracotomy
Early-stage NSCLC
Consolidation-predominant

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases