Clinical trial · Interventional
Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma
Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Local IRB closed the study due to poor accural.
Summary
Brief summary (as posted)
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention (in this case, the stereotactic radiation boost). Phase I studies also try to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the stereotactic radiation treatment is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved a stereotactic radiation boost for your type of cancer. In this research study, the investigators are looking for the highest dose of the stereotactic radiation boost that can be given safely. Because the stereotactic radiation boost is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects you experience; the goal is to improve the likelihood of successfully treating the tumor.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Boost
- description
- Escalating doses of stereotactic body radiation therapy (SBRT)
- interventionNames
- Radiation: Stereotactic Body Radiotherapy
Primary outcomes (2)
- measure
- Determination of MTD
- timeFrame
- 2 years
- description
- Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for poor-prognosis oropharyngeal squamous cell carcinoma
- measure
- Two Year Local Control Rate
- timeFrame
- 2 years
- description
- Local failure is defined as biopsy-proven recurrent disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated histologically or cytologically confirmed T2-4, N0-3 HPV16-negative oropharyngeal squamous cell carcinoma or HPV16 positivity with at least a 10 pack-year smoking habit * Measurable disease * Life expectancy of greater than 6 months Exclusion Criteria: * Other active malignancy within the past 5 years (except for non-melanoma skin cancer or carcinoma in situ of the cervix) * Primary tumor size \> 6 cm * Prior history of head and neck radiotherapy * Receiving any other study agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin * Uncontrolled intercurrent illness * Pregnant or breastfeeding * HIV positive on combination antiretroviral therapy
References
Publications (0)
Data not yet available