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OpenTrials
Completed

NCT Number: NCT00918762

Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx

RATIONALE: Transoral robotic surgery may make it easier to find and remove benign or malignant tumors of the larynx and pharynx and cause less damage to normal tissue. It is not yet known whether transoral robotic surgery is more effective than standard surgery in diagnosing and treating larynx and pharynx tumors.

PURPOSE: This phase I trial is studying how well transoral robotic surgery works compared with standard surgery in treating patients with benign or malignant tumors of the larynx or pharynx.

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Key information

About this study

OBJECTIVES:

Primary

  • Evaluate the potential benefits of using the transoral robotic surgical approach against the conventional open and transoral approaches in patients with benign or malignant disease involving the larynx and pharynx.

Secondary

  • Determine the proportion of laryngeal and pharyngeal surgical procedures where the surgical exposure is adequate to allow the successful completion of the surgical resection using the transoral robotic surgical approach.

OUTLINE: Patients are assigned to transoral robotic surgery or standard therapy consisting of conventional transoral endoscopic or open approach according to their preference.

Patients undergo planned surgical procedures (either diagnostic or therapeutic) appropriate for their disease in the larynx or pharynx via the transoral robotic surgical approach or the conventional transoral endoscopic or open approach.

Patients complete the Functional Assessment of Cancer Therapy Head and Neck Scale, the Performance Status Scale for Head and Neck Cancer Patients, and the University of Washington Quality of Life Scale at baseline and at 3 and 6 months. Patients also undergo voice analysis by acoustic analyses, and speech and swallow pathology evaluation by videostroboscopy and modified barium swallow.

After completion of study procedure, patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 80 patients will be accrued to the control group (standard conventional surgery) and 30 patients will be accrued to the robotic surgery group.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Benign or malignant disease of the larynx or pharynx that requires surgical intervention for either diagnostic or therapeutic purposes
  • Malignant disease must meet the following criteria:
  • Histologically confirmed diagnosis of 1 of the following:
  • Glottic cancer (T1, T2, and T3)
  • Supraglottic cancer (T1, T2, and T3)
  • Hypopharyngeal cancer (T1 and T2)
  • Oropharyngeal cancer (T1, T2, and T3)
  • Nasopharyngeal cancer (T1 and T2)
  • Resectable involved lymph nodes
  • No invasion of osseous and/or osseocartilaginous structures including the following:
  • Mandibular bone
  • Thyroid cartilage
  • Hyoid bone
  • Cricoid bone
  • Vertebral body
  • No pharyngeal wall or tongue-based involvement requiring resection of > 50% of the posterior pharyngeal wall or tongue base
  • No radiological confirmation of carotid artery involvement
  • No fixation of tumor to the prevertebral fascia
  • No bilateral arytenoid involvement
  • No surgical defect requiring open approach for reconstruction
  • No evidence of distant metastasis

PATIENT CHARACTERISTICS:

  • Not pregnant
  • No unexplained fever and/or untreated active infection
  • No medical conditions contraindicating general anesthesia
  • No inadequate jaw opening due to prior head and neck surgery, trauma, or radiotherapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

assessment of therapy complications

Procedure

diagnostic endoscopic surgery

Procedure

quality-of-life assessment

Procedure

therapeutic conventional surgery

Procedure

therapeutic endoscopic surgery

Procedure

Transoral Robotic Surgery

Procedure

video-assisted surgery

Procedure

Primary outcomes

  1. Operative time that directly affects operative cost

    Time frame: post operative

Secondary outcomes

  1. Blood loss

    Time frame: During surgery

  2. Intra-operative and post-operative complications

    Time frame: during the operation and post operative

  3. Need for reconstruction

    Time frame: post operative

  4. Margins status

    Time frame: post operative

  5. Length of hospital stay

    Time frame: during time as inpatient

  6. Tracheostomy and PEG dependence

    Time frame: post operative

  7. Days to oral intake

    Time frame: post operative

  8. Time to locoregional recurrence

    Time frame: post operative

  9. Speech intelligibility

    Time frame: post operative

  10. Quality of life

    Time frame: 3 months and 6 month following completion of surgery

  11. Postoperative pain

    Time frame: post operative

  12. Proportion of robotic surgical cases where adequate surgical exposure allowed for successful operation completion

    Time frame: post operative

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study Assessing the Use of DA VINCI® Robotic Surgical System in Laryngeal and Pharyngeal Surgeries

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2009
Registry last updated
May 9, 2014

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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