Clinical trial · Interventional
OPSCC N0 Nodal Control With Reduced IMRT
A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study had very specific inclusion/exclusion criteria and difficult to recruit
Summary
Brief summary (as posted)
The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering. The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.
Conditions
Conditions (2)
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 (Human Papillomavirus)-Associated | — | UNRESOLVED | — |
| Oropharyngeal Squamous Cell Carcinoma (OPSCCA) | Oropharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 39.6 Gy radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reduced Intensity Radiation
- description
- 39.6 Gy radiation to clinically uninvolved cervical lymphatics
- interventionNames
- Radiation: 39.6 Gy radiation
Primary outcomes (1)
- measure
- N0 Nodal Control Rate
- timeFrame
- Up to 3 years post treatment
- description
- Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)
Secondary outcomes (3)
- measure
- Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient must be clinically referred for radiation for stage I-IVb OPSCCA * tumor must be HPV-associated p16+ * patient must be able to lie flat and tolerate immobilization systems Exclusion Criteria: * patients may not be receiving any investigational agents * prior radiation to head and neck * any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years * any major medical, psychiatric, or neurologic illness * pregnant or breastfeeding women
References
Publications (0)
Data not yet available