Clinical trial · Interventional
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
NCT03656133CI-TRIAL-00103785completedN/AResults postedClinicalTrials.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 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.
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 |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy fractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy Fractionation
- description
- Investigators will use an individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) to improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks). Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
- interventionNames
- Radiation: Radiotherapy fractionation
Primary outcomes (1)
- measure
- Percentage of Response at Week 4 of Treatment
- timeFrame
- At 4 weeks of treatment
- description
- Fractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Age \< 18 * Positive urine pregnancy test * Evidence of distant metastases * 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 * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Patients with a medical condition or social situation that at the discretion of the PI would preclude them from completion of the trial
References
Publications (0)
Data not yet available
No reference posted for this study.