Trials / Recruiting
RecruitingNCT04220749
Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma
A Phase II Randomized Trial for HPV-Negative Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.
Detailed description
This study is designed as a randomized phase II study. Patients will be randomized between current standard of care treatment (Arm 1) vs. TOS (Arm 2) in a 1:1 ratio. Additionally, patients will be stratified according to T stage (T1 vs. T2); N stage (N0/1 vs. N2/3) The randomized phase II design is required for three reasons: 1. The randomization will provide an appropriate control group to serve as a comparator for the experimental arm. Historical or contemporaneous non-randomized controls would not be appropriate due to the multitude of biases that could be introduced by patient selection and other confounders. 2. A small sample size will allow for adequate power to assess for progression-free survival, and also an assessment of quality of life, overall survival and toxicity. 3. The results will allow for a decision as to whether a multi-institutional phase III trial is warranted, and inform the design of such a trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiation | Standard of Care: Radiation +/- Chemotherapy |
| PROCEDURE | Trans-Oral Surgery (TOS) + Neck Dissection | Trans-Oral Surgery (TOS) + Neck Dissection (plus radiation, if required) |
Timeline
- Start date
- 2020-06-25
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
- First posted
- 2020-01-07
- Last updated
- 2020-09-04
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04220749. Inclusion in this directory is not an endorsement.