Clinical trial · Interventional
Shortened Course Adjuvant Radiotherapy Following TORS
A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.
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 |
|---|---|---|---|
| HPV-Associated Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shortened Course Adjuvant Radiotherapy Following TORS | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Shortened Course Adjuvant Radiotherapy
- description
- The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week). Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.
- interventionNames
- Radiation: Shortened Course Adjuvant Radiotherapy Following TORS
Primary outcomes (1)
- measure
- Locoregional control
- timeFrame
- 2 years
- description
- To determine whether disease recurs locally (at primary site) or in regionally in the nodes of the neck
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years old * Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization * Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed) * Pathologic N0-N1 disease (per AJCC 8th Ed) * Preoperative plasma ctHPVDNA of ≥ 50 copies/mL * Undetectable postoperative plasma ctHPVDNA * ECOG Performance Status 0-1 Exclusion Criteria: * Prior external beam radiation therapy to the head and neck * Presence of T4 disease * ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition) * Presence of distant metastatic disease * Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (0)
Data not yet available