Trials / Recruiting
RecruitingNCT05800574
Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
A Phase II Investigation of Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer Patients Managed With Primary (Chemo) Radiation
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- Sponsor
- Fox Chase Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.
Detailed description
This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck. Patients positive for p16 status will be approached for consent during the pre-treatment intake process. Contralateral neck progression will be measured by PET (positron emission tomography)/CT scans. Xerostomia will be measured by the EORTC QLQ (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) H\&N35 at 6, 12, and 24 months. Patients will remain on study treatment for 6-7 weeks or until unacceptable toxicity or withdrawal of consent. Disease free survival (DFS) and overall survival (OS) will be assessed until 24 months after completion of study treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Radiation therapy (5 days for 7 weeks) | Mon-Fri (5 days for 7 weeks), total 35 fractions over 35 treatment days of radiation therapy (RT) |
| RADIATION | Radiation therapy (5 days for 6 weeks) | Mon-Fri (5 days for 6 weeks), total 35 fractions over 30 treatment days of RT (two doses 6 hours apart except for the last 6th Friday of the 6 weeks ) |
| DRUG | Cisplatin | Cisplatin, 40mg/m2 (weekly for 7 weeks) |
Timeline
- Start date
- 2023-03-14
- Primary completion
- 2025-09-23
- Completion
- 2027-09-23
- First posted
- 2023-04-05
- Last updated
- 2024-12-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05800574. Inclusion in this directory is not an endorsement.