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NCT03656133

Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers

Completed NA Results posted Last updated 20 February 2026
What this trial tests

NA trial testing Radiotherapy fractionation in Oropharyngeal Cancer in 55 participants. Completed in 26 March 2024.

Timeline
26 September 2018
Primary endpoint
14 March 2022
26 March 2024

Quick facts

Lead sponsorH. Lee Moffitt Cancer Center and Research Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment55
Start date26 September 2018
Primary completion14 March 2022
Estimated completion26 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Oropharyngeal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Response at Week 4 of Treatment Primary · At 4 weeks of treatment

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.

GroupValue95% CI
Radiotherapy Fractionation61.2
Rate of Complete Response at 2-3 Months Secondary · 2-3 months post treatment

Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy

Complete anatomic and/or metabolic response
GroupValue95% CI
Radiotherapy Fractionation98.1
Partial anatomic and/or metabolic response
GroupValue95% CI
Radiotherapy Fractionation2.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Radiotherapy Fractionation
Serious: 1/55 (2%)
Deaths: 2/55

Serious adverse events (2 terms)

ReactionSystemRadiotherapy Fractionation
DiarrheaGastrointestinal disorders
NauseaGastrointestinal disorders
Other adverse events (7 terms — click to expand)

ReactionSystemRadiotherapy Fractionation
Mucositis oralGastrointestinal disorders
Dermatitis radiationInjury, poisoning and procedural complications
Pharyngeal mucositisRespiratory, thoracic and mediastinal disorders
DiarrheaGastrointestinal disorders
Dry mouthGastrointestinal disorders
NauseaGastrointestinal disorders
Sore throatRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Diarrhea, Nausea.

Data from ClinicalTrials.gov NCT03656133 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mathematical Models of Cancer: When to Predict Novel Therapies, and When Not to.
    Brady R, Enderling H. · · 2019 · cited 100× · PMID 31338741 · DOI 10.1007/s11538-019-00640-x
  2. HPV-driven oropharyngeal cancer: current knowledge of molecular biology and mechanisms of carcinogenesis.
    Pan C, Issaeva N, Yarbrough WG. · · 2018 · cited 79× · PMID 31093365 · DOI 10.1186/s41199-018-0039-3
  3. Consensuses, controversies, and future directions in treatment deintensification for human papillomavirus-associated oropharyngeal cancer.
    Kang JJ, Yu Y, Chen L, Zakeri K, et al · · 2023 · cited 52× · PMID 36305841 · DOI 10.3322/caac.21758
  4. Forecasting Individual Patient Response to Radiation Therapy in Head and Neck Cancer With a Dynamic Carrying Capacity Model.
    Zahid MU, Mohsin N, Mohamed ASR, Caudell JJ, et al · · 2021 · cited 51× · PMID 34102299 · DOI 10.1016/j.ijrobp.2021.05.132
  5. Mathematical modeling of radiotherapy and its impact on tumor interactions with the immune system.
    Bekker RA, Kim S, Pilon-Thomas S, Enderling H. · · 2022 · cited 37× · PMID 35447601 · DOI 10.1016/j.neo.2022.100796
  6. Mathematical modeling of radiotherapy: impact of model selection on estimating minimum radiation dose for tumor control.
    Kutuva AR, Caudell JJ, Yamoah K, Enderling H, et al · · 2023 · cited 7× · PMID 37901317 · DOI 10.3389/fonc.2023.1130966
  7. Mathematical Oncology: How Modeling Is Transforming Clinical Decision-Making.
    Scibilia KR, Gallagher K, Masud MA, Robertson-Tessi M, et al · · 2025 · cited 3× · PMID 41105675 · DOI 10.1158/0008-5472.can-25-0750
  8. Mathematical oncology: A new frontier in cancer biology and clinical decision making: Comment on "Improving cancer treatments via dynamical biophysical models" by M. Kuznetsov, J. Clairambault & V. Volpert.
    Enderling H. · · 2022 · cited 1× · PMID 34857476 · DOI 10.1016/j.plrev.2021.11.005

Verify or expand the search:

Other recruiting trials for Oropharyngeal Cancer

Currently open trials in the same condition.

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03656133.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing