Clinical trial · Interventional
Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer
Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors
NCT01254734CI-TRIAL-00016026terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study will be rewritten as a data registry study
Summary
Brief summary (as posted)
RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.
Conditions
Conditions (55)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Adenoid Cystic Carcinoma of the Oral Cavity | Oral Cavity Adenoid Cystic Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lymphoepithelioma of the Nasopharynx | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lymphoepithelioma of the Oropharynx | — | UNRESOLVED | — |
| Recurrent Mucoepidermoid Carcinoma of the Oral Cavity | Oral Cavity Mucoepidermoid Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Nasopharynx |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| transoral robotic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo transoral robotic microsurgery.
- interventionNames
- Procedure: transoral robotic surgery
- Other: laboratory biomarker analysis
- Procedure: quality-of-life assessment
Primary outcomes (6)
- measure
- Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors
- timeFrame
- From 6 months to 3 years after completion of study treatment
- measure
- Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors
- timeFrame
- From 6 months to 3 years after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space * Surgical access is amenable to treatment with conventional transoral surgical procedures * ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach * Patients should have no serious acute infection * Patients must sign a study-specific informed consent form Exclusion Criteria: * Evidence of distant metastases (below the clavicle) by clinical or radiographic measures * ASA score \> 4; ECOG PS score \> 3 * Pregnancy (during first or 3rd trimester - due to risks of anesthesia) * The presence of medical conditions which contraindicate general anesthesia * Unexplained fever or untreated, active infection * Inability to obtain exposure to allow performance of the planned transoral surgical procedure * Proposed surgical site with history of prior treatment: radiation * Tumor adherent to carotid artery or jugular vein * Fixation to pre-vertebral tumor * Mandibular invasion
References
Publications (0)
Data not yet available
No reference posted for this study.