Trials / Active Not Recruiting
Active Not RecruitingNCT04638465
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma Based On The AJCC 8th Edition Staging Manual
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Nebraska Methodist Health System · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effects, good and/or bad, of treating participants with HPV-mediated oropharyngeal cancer, with less treatment, using the new staging system. The investigators believe this treatment will provide the same effectiveness as the usual treatment, but decrease the side effects. The radiation doses, chemotherapy doses, and the type of surgical approaches that will be used in this treatment protocol have all been previously investigated. Previous research suggests that this can be done safely, but there has not been a study done basing treatment on the new staging system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transoral robotic surgery | Transoral resection with neck dissection |
| DRUG | Cisplatin - Dose Level 1 | 6 Cycles of 40 mg/m2 |
| DRUG | Cisplatin - Dose Level 2 | 7 Cycles of 40 mg/m2 |
| RADIATION | Dose Level 1 | 60 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week |
| RADIATION | Dose Level 2 | 70 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week |
Timeline
- Start date
- 2018-08-06
- Primary completion
- 2025-01-01
- Completion
- 2030-01-01
- First posted
- 2020-11-20
- Last updated
- 2023-11-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04638465. Inclusion in this directory is not an endorsement.