Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy (ROMAN)

December 18, 2018 updated by: Istituto Clinico Humanitas

Prospective, Randomized, Multicentric Study On Videothoracoscopic (Vats) Vs Robotic Approach For Lobectomy Or Anatomical Segmentectomy In Patients Affected By Early Lung Cancer (ROMAN)

This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Recruiting
        • Thoracic surgery Division, Istituto Clinico Humanitas
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giulia Veronesi, MD
        • Sub-Investigator:
          • Marco Alloisio, MD
        • Sub-Investigator:
          • Alberto Testori, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age older than 18 years old
  • Known or suspected lung cancers
  • Patients in clinical stage T1-T2, N0-N1 candidate to surgery lobectomy or anatomical segmentectomy
  • ASA-1-2-3

Exclusion Criteria:

  • Clinical stage >II
  • Severe heart disease
  • Alcohol abuse
  • Renal impairment (creatinine >2.5)
  • Presence of serious comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VATS GROUP
VATS lobectomy or segmentectomy
Procedure: VATS
Thorax thoracoscopic surgery (lobectomy)
Other Names:
  • Minimally invasive video-assisted surgery
Active Comparator: RATS GROUP
Robotic lobectomy or segmentectomy
Procedure: RATS
Thorax robotic surgery (lobectomy)
Other Names:
  • Minimally invasive robot-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative complications: conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other)
Time Frame: date of Surgery
date of Surgery
Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days
Time Frame: within 90 days
within 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of surgery
Time Frame: date of Surgery
date of Surgery
Number of resected lymph nodes and upstaging
Time Frame: date of Surgery
date of Surgery
Proportion of patients who undergo complete resection during the procedure
Time Frame: date of Surgery
date of Surgery
Postoperative hospital stay
Time Frame: 2 weeks
2 weeks
Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge
Time Frame: 2 weeks, 6 months and 12 months
2 weeks, 6 months and 12 months
Quality of life by EORTC QOL-C30
Time Frame: 2 weeks, 6 months and 12 months
2 weeks, 6 months and 12 months
Duration of analgesic use after discharge and time to return to normal daily activity
Time Frame: within 90 days
within 90 days
Postoperative respiratory function: FEV 1, PEF and CV
Time Frame: 6 month postoperatively
6 month postoperatively
Rate of local and distant recurrence and disease free survival
Time Frame: 24 months
24 months
Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations
Time Frame: before surgery, 2 hours after surgery and at 3rd and 14th postoperative day
before surgery, 2 hours after surgery and at 3rd and 14th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Collaborators

Fondazione Umberto Veronesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2017

Primary Completion (Anticipated)

March 6, 2022

Study Completion (Anticipated)

March 6, 2023

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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