NCT03656133Completed
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy Fractionation for Patients With HPV+ Oropharyngeal Cancers
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
This study is to determine whether a mathematical model can be used to choose a radiation delivery method to improve the rate of a rapid response.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 30 Aug 2018
- Start date
- 26 Sept 2018
- Primary completion date
- 14 Mar 2022
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT03656133
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 26 Sept 2018 to the primary completion date, 14 Mar 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Other illness
- Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that remove all clinically and radiographically evident disease
- Patients with a medical condition or social situation that at the discretion of the PI would preclude them from completion of the trial
Age
- Age \< 18
Other
- Positive urine pregnancy test
- Evidence of distant metastases
Who the study is looking for
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years
- Pathologically (histologically or cytologically) proven diagnosis of p16+ or HPV+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, and may consist of pathology, palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
- American Joint Committee on Cancer (AJCC) 8th edition staging T1-3 N0-1 MO
- Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- CT or MRI performed at least 1 week apart. This can consist of diagnostic imaging and radiation therapy planning imaging.
- No evidence of distant metastases
- Eastern Cooperative Oncology Group Performance Status 0 to 3
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| H Lee Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.