Clinical trial · Observational
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
NCT05600842CI-TRIAL-00110374recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.
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 Positive Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-Modulated Radiation Therapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- De-escalated radiotherapy
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy (IMRT)
Primary outcomes (1)
- measure
- 2-Year Progression-Free Survival
- timeFrame
- Given the natural history of this disease, PFS will be monitored up to 2 years from registration
- description
- Progression-free survival (PFS) is defined as the time from registration to disease progression or death from any cause.
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration
- description
- Survival time will be measured from the date of randomization to the date of death due to any cause or last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status. * Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible; * History/physical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss; * Age ≥ 18; * PET/CT within 6 weeks prior to registration; * Patients must sign a study-specific informed consent form prior to study entry. * Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial. Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; * Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded; * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; * Receipt of prior radiotherapy that would result in overlap with proposed field.
References
Publications (0)
Data not yet available
No reference posted for this study.