Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors (TORS)

March 25, 2024 updated by: Gustave Roussy, Cancer Campus, Grand Paris
Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without concomitant chemotherapy. These treatments have long-time functional side effects and consequences on the quality of life. Transoral robotic surgery has been developing since 2006 by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for transoral surgery of head and neck cancers, using previous generations of da Vinci. The last generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014 and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The objective of our study is therefore to study the feasibility of this transoral robotic surgery for head and neck cancers, using the da Vinci Xi.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • France
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805
        • Gustave Roussy Cancer Campus Grand Paris

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

Description

Inclusion Criteria:

  1. Patient >/= 18
  2. WHO Status 0-2
  3. ENT cancer or solid tumor histologically proven regardless histology
  4. All maps of the head and neck and any stage
  5. surgically resectable according to clinical examination and preoperative investigations, confirmed in multidisciplinary meeting

  6. Treatment:

    • First-line
    • Or after induction chemotherapy
    • Or local recurrence regardless of the previous treatment
    • Or second location in irradiated
  7. Transoral exposition of tumor, assessed preoperatively during endoscopy during the balance of extension of the lesion
  8. The patient must have accepted the possibility of surgical conversion open surgery
  9. The patient must have been clearly informed of the study and have formulated his non-opposition to participate

Exclusion Criteria:

  1. Metastasis (s) clinical or radiological remote, inaccessible (s) to a local curative treatment
  2. post-treatment tumor progression and / or early recurrence < 3 months
  3. Unresectable tumor by robotic transorally: bone infiltration, deep infiltration of soft tissues, unresectable lymphadenopathy
  4. Contraindications to the suspension for transoral tumor Exposure: Dental fragility against-indication for cervical extension
  5. Pathology against intercurrent-indicating cancer surgery
  6. Pregnancy
  7. Inability to submit to medical monitoring study for geographical, social or psychological.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with head and neck cancer
Device: Transoral robotic-assisted surgery with Da Vinci Xi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achievement rate of transoral robotic surgery
Time Frame: Assessed up to five years
Assessed up to five years

Collaborators and Investigators

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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

April 1, 2015

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimated)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00173-46
  • 2015/2235 (Other Identifier: CSET number)

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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