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

Barbara Ann Karmanos Cancer Institute

Status and phase: Completed; Phase 1

Conditions: Perioperative/Postoperative Complications; Precancerous Condition; Head and Neck Cancer

Treatments: Procedure: therapeutic conventional surgery; Procedure: diagnostic endoscopic surgery; Procedure: assessment of therapy complications; Procedure: video-assisted surgery; Procedure: quality-of-life assessment; Procedure: transoral robotic surgery; Procedure: therapeutic endoscopic surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00918762

P30CA022453 (U.S. NIH Grant/Contract)

CDR0000642940

WSU-2008-022

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

daVinci® Robotic Surgical System

Experimental group

Description:

Participants will undergo a planned surgical procedures via the robotic approach.

Treatment:

Procedure: quality-of-life assessment

Procedure: transoral robotic surgery

Procedure: therapeutic endoscopic surgery

Procedure: therapeutic conventional surgery

Procedure: diagnostic endoscopic surgery

Procedure: assessment of therapy complications

Procedure: video-assisted surgery