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Head and Neck CancerPhase 1NCT00918762

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

A Phase 1 study testing assessment of therapy complications, diagnostic endoscopic surgery and quality-of-life assessment in people with Head and Neck Cancer and Perioperative/Postoperative Complications, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
assessment of therapy complications, diagnostic endoscopic surgery and quality-of-life assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
May 2009to Oct 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
assessment of therapy complications, diagnostic endoscopic surgery, quality-of-life assessment, therapeutic conventional surgery, therapeutic endoscopic surgery
Keywords
perioperative/postoperative complications, precancerous condition, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage I lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage I lymphoepithelioma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II lymphoepithelioma of the oropharynx
Medical subject headings
Head and Neck Neoplasms, Postoperative Complications, Precancerous Conditions, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • assessment of therapy complicationsProcedure or surgery

  • diagnostic endoscopic surgeryProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

  • therapeutic conventional surgeryProcedure or surgery

  • therapeutic endoscopic surgeryProcedure or surgery

  • transoral robotic surgeryProcedure or surgery

  • video-assisted surgeryProcedure or surgery

Study groups in NCT00918762
Study groupRoleWhat they receive
daVinci® Robotic Surgical SystemExperimentalParticipants will undergo a planned surgical procedures via the robotic approach.
Receives: Procedure: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative time that directly affects operative cost

    Measured: post operative

Secondary outcomes (12)

  1. Blood loss

    Measured: During surgery

  2. Intra-operative and post-operative complications

    Measured: during the operation and post operative

  3. Need for reconstruction

    Measured: post operative

  4. Margins status

    Measured: post operative

  5. Length of hospital stay

    Measured: during time as inpatient

  6. Tracheostomy and PEG dependence

    Measured: post operative

  7. Days to oral intake

    Measured: post operative

  8. Time to locoregional recurrence

    Measured: post operative

  9. Speech intelligibility

    Measured: post operative

  10. Quality of life

    Measured: 3 months and 6 month following completion of surgery

  11. Postoperative pain

    Measured: post operative

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

    Measured: post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionFeb 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00918762
Sponsor's protocol ID
CDR0000642940
Other IDs
P30CA022453, WSU-2008-022
Status last verified
May 2014
First submitted
9 Jun 2009
Last updated
9 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing assessment of therapy complications, diagnostic endoscopic surgery and quality-of-life assessment in people with Head and Neck Cancer and Perioperative/Postoperative Complications, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative time that directly affects operative cost (time frame: post operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00918762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.

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