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Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
A Phase II Study of Transoral Robotic Surgery With Adjuvant Therapy for Surgically Resectable HPV-positive Oropharyngeal Cancer
2 other identifiers
interventional
1
1 country
1
Brief Summary
Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as little as possible. Researchers think that this approach may help to control the disease and avoid such long-term side effects. The goal of this clinical research study is to learn if minimally-invasive transoral robotic surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System. Researchers also want to learn if this surgery affects participants' ability to speak and swallow.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2014
CompletedFirst Posted
Study publicly available on registry
August 26, 2014
CompletedStudy Start
First participant enrolled
September 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2017
CompletedDecember 15, 2017
December 1, 2017
3.2 years
August 22, 2014
December 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to local-regional recurrence (TTLRR)
Primary efficacy endpoint is time to local-regional recurrence (TTLRR). TTLRR measured from surgery (using minimally-invasive Transoral Robotic Surgery (TORS)) date to first date that local-regional recurrence disease is objectively documented or to last follow-up date if local-regional recurrence has not occurred during follow-up.
6 months after surgery
Study Arms (1)
Transoral Robotic Surgery (TORS)
EXPERIMENTALTransoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow \[MBS\] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire.
Interventions
Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm.
MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.
Questionnaires about speech and swallowing function completed at baseline, 1 - 4 weeks after surgery, and at 6 months, 12 months, and at 24 months.
Eligibility Criteria
You may qualify if:
- Patients with a previously untreated, T1 or T2, N0-N2b transorally resectable (as determined by the treating surgeon), histologically proven HPV positive, squamous cell carcinoma (SCC) of the oropharynx.
- Eastern Cooperative Oncology Group (ECOG) PS 0-2.
- Age \>/= 18 years.
- Negative serum pregnancy test in females of childbearing potential.
- Patients must sign a study-specific informed consent form prior to treatment.
You may not qualify if:
- Evidence of distant metastases (below the clavicle) by clinical or radiographic examination.
- Evidence of any other primary cancers or metastases. Evidence of deep soft-tissue or bony invasion, which would preclude TMIS by clinical and/or radiographic exam.
- Contraindications to general anesthesia.
- Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with tumors whose resection would necessitate a free-tissue transfer for reconstruction of the surgical defect.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael E. Kupferman, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2014
First Posted
August 26, 2014
Study Start
September 23, 2014
Primary Completion
December 8, 2017
Study Completion
December 8, 2017
Last Updated
December 15, 2017
Record last verified: 2017-12