Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06323460
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Carboplatin — DRUG
    Given IV
  • Cisplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • External Beam Radiation Therapy — RADIATION
    Undergo external beam radiotherapy
  • Paclitaxel — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.

Key Dates

Start date
Mar 21, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (reduced > 95% of TTMV, external beam radiotherapy)
    Patients undergo external beam radiotherapy daily for 5 days a week for 4 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 4 weeks. Patients undergo blood sample collection for circulating tumor DNA testing at week 4. Patients with reduced \> 95% of TTMV undergo external beam radiotherapy QD 5 days a week for 5 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 5 weeks. Patients also undergo blood sample collection during screening and throughout the trial.
  • Active Comparator: Arm II (not reduced > 95% of TTMV, external beam radiotherapy)
    Patients undergo external beam radiotherapy daily for 5 days a week for 4 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 4 weeks. Patients undergo blood sample collection for circulating tumor DNA testing at week 4. Patients without reduced \> 95% of TTMV undergo external beam radiotherapy daily for 5 days a week for 7 weeks. Patients also receive cisplatin IV weekly or every 3 weeks or carboplatin/paclitaxel IV weekly at the discretion of treating physician for 7 weeks. . Patients also undergo blood sample collection during screening and throughout the trial.

Primary Outcome Measure

Positron emission tomography complete response [ Time Frame: At 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Sujith Baliga
[email protected]
614-293-5066
Sujith Baliga (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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