TriangleNCT03656133 · REGISTRY CONDITION SEARCH
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2026-02-20
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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)
- intervention Names
- Radiation: Radiotherapy fractionation
- label
- Radiotherapy Fractionation
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Radiotherapy Fractionation
- description
- Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
- name
- Radiotherapy fractionation
- type
- RADIATION
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 55
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- measure
- Percentage of Response at Week 4 of Treatment
- time Frame
- At 4 weeks of treatment
- secondary Outcomes
- description
- Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy
- measure
- Rate of Complete Response at 2-3 Months
- time Frame
- 2-3 months post treatment
Full study description
- brief Summary
- 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.
- detailed Description
- Investigators hypothesize that using individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) may improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-8da5bd366d8a943af723
- requested nct id
- NCT03656133
- primary nct id
- NCT03656133
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
- payload sha256
- f86a3af2c1fbcfb0d6010f2d04f8c85e889c1d51c12422e209ae59e1deab782c
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-8da5bd366d8a943af723
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT03656133
- occurrences
- context exact
- NCT03656133
- end
- 11
- exact text
- NCT03656133
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Laryngeal Cancer
- query disease state id
- ds-laryngeal-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
- source file sha256
- fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
- source json pointer
- /studies/72/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- d3836e2739afc3e62346a0e6ae27d4a8915e8332d301e479b3f2a1c4208f86de
Preserved source evidence · Not medical advice