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CompletedNCT02517125TORSUpdated Mar 30, 2026

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

An interventional study of Transoral robotic-assisted surgery with Da Vinci Xi in Head and Neck Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 100 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Patients with head and neck cancer

    Device: Transoral robotic-assisted surgery with Da Vinci Xi

Interventions

  • DeviceTransoral robotic-assisted surgery with Da Vinci Xi
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What researchers measure

Primary outcomes

  1. Achievement rate of transoral robotic surgery

    Time frame: Assessed up to five years

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Study locations

1 site
  • Gustave Roussy Cancer Campus Grand Paris
    Villejuif, Val de Marne 94805, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02517125
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Aug 6, 2015
Start date
Apr 2015
Primary completion
Nov 2025
Completion
Nov 4, 2025
Last update
Mar 30, 2026
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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