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

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transoral robotic-assisted surgery with Da Vinci Xi
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gustave Roussy Cancer Campus Grand Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with head and neck cancer

Arm Description

Outcomes

Primary Outcome Measures

Achievement rate of transoral robotic surgery

Secondary Outcome Measures

Full Information

First Posted
August 4, 2015
Last Updated
January 20, 2023
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02517125
Brief Title
Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors
Acronym
TORS
Official Title
Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with head and neck cancer
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transoral robotic-assisted surgery with Da Vinci Xi
Primary Outcome Measure Information:
Title
Achievement rate of transoral robotic surgery
Time Frame
Assessed up to five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient >/= 18 WHO Status 0-2 ENT cancer or solid tumor histologically proven regardless histology All maps of the head and neck and any stage surgically resectable according to clinical examination and preoperative investigations, confirmed in multidisciplinary meeting Treatment: First-line Or after induction chemotherapy Or local recurrence regardless of the previous treatment Or second location in irradiated Transoral exposition of tumor, assessed preoperatively during endoscopy during the balance of extension of the lesion The patient must have accepted the possibility of surgical conversion open surgery The patient must have been clearly informed of the study and have formulated his non-opposition to participate Exclusion Criteria: Metastasis (s) clinical or radiological remote, inaccessible (s) to a local curative treatment post-treatment tumor progression and / or early recurrence < 3 months Unresectable tumor by robotic transorally: bone infiltration, deep infiltration of soft tissues, unresectable lymphadenopathy Contraindications to the suspension for transoral tumor Exposure: Dental fragility against-indication for cervical extension Pathology against intercurrent-indicating cancer surgery Pregnancy Inability to submit to medical monitoring study for geographical, social or psychological.
Facility Information:
Facility Name
Gustave Roussy Cancer Campus Grand Paris
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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