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

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ClinicalTrials.gov Identifier: NCT02517125
Recruitment Status : Recruiting
First Posted : August 6, 2015
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: Transoral robotic-assisted surgery with Da Vinci Xi Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors
Study Start Date : April 2015
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Achievement rate of transoral robotic surgery [ Time Frame: Assessed up to five years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517125


Contacts
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Contact: Philippe Gorphe, MD 0142114586 ext +33 philippe.gorphe@gustaveroussy.fr

Locations
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France
Gustave Roussy Cancer Campus Grand Paris Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Philippe Gorphe, MD    0142114586 ext +33    philippe.gorphe@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02517125     History of Changes
Other Study ID Numbers: 2015-A00173-46
2015/2235 ( Other Identifier: CSET number )
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms