Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Another trial in the department directly competes for the the same patient population
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified Barium Swallow (MBS) | Procedure | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Transoral Robotic Surgery (TORS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transoral Robotic Surgery (TORS)
- description
- 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. 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.
- interventionNames
- Procedure: Transoral Robotic Surgery (TORS)
- Procedure: Modified Barium Swallow (MBS)
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Time to local-regional recurrence (TTLRR)
- timeFrame
- 6 months after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Eastern Cooperative Oncology Group (ECOG) PS 0-2. 3. Age \>/= 18 years. 4. Negative serum pregnancy test in females of childbearing potential. 5. Patients must sign a study-specific informed consent form prior to treatment. Exclusion Criteria: 1. Evidence of distant metastases (below the clavicle) by clinical or radiographic examination. 2. 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. 3. Contraindications to general anesthesia. 4. Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study. 5. 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 6. Patients with tumors whose resection would necessitate a free-tissue transfer for reconstruction of the surgical defect.
References
Publications (0)
Data not yet available