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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transoral robotic-assisted surgery with Da Vinci Xi

Device

Primary outcomes

Achievement rate of transoral robotic surgery

Time frame: Assessed up to five years

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: TORS

Important dates

Study start: 2015
Primary completion: 2025
Study completion: 2025
First posted: Aug 6, 2015
Registry last updated: Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed