Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)

May 13, 2026 updated by: Sara Medek

Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)

This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research is to determine if a decrease in the dose of radiation to regions which have no visible cancer will be as effective as the standard dose. The dose to all visible cancer remains unchanged to the standard radiation approach. The researchers believe that a lower dose could be just as helpful for treatment, while reducing the side effects of radiation and improving quality of life.

The current standard care treatment for OPSCC can have debilitating side effects. Using a decreased dose of 30 Gy from 46-54 Gy to regions without visible cancer but which have a risk of microscopic cancer might be just as effective for treating cancer with less side effects. The combination of these approaches is not considered the current standard of care. Patients will continue to receive standard systemic therapy of cisplatin during radiation therapy.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sara Medek, MD

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Sara Medek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.
  2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.
  3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.
  4. Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation.
  5. Age ≥18 years.
  6. ECOG performance status ≤2.
  7. Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist.
  8. Women of child-bearing potential and men must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • 1. Patients with metastatic or recurrent disease.

    2. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive).

    3. Prior radiotherapy resulting in overlap of radiation therapy fields.

    4. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study.

    5. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator.

    6. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the Investigator.

    7. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or not preferable, in the opinion of the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reduced Elective Nodal and CTV Dose
Reduction in primary tumor and nodal CTV dose to 30 Gy.
Drug: Cisplatin
Subjects will continue to receive standard systemic therapy of cisplatin during radiation therapy. Weekly SOC Cisplatin at a dose of 40mg/m2 or every 3-week dosing of 100mg/m2 will be administered per institutional guidelines during radiation therapy. The first cisplatin infusion should be initiated during the window from 24 hours before, to 48 hours after the first scheduled radiation treatment. Skipped cisplatin infusions should not be made up, and the last cisplatin infusion should be no later than 7 days after the last fraction of radiation.
Radiation: Radiotherapy
Radiotherapy will involve a sequential boost approach. Treatment will begin with coverage of the primary site and elective nodal regions to 30 Gy, after which treatment volumes will be reduced to primary site and involved nodes only with PTV margin to 70 Gy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS)
Time Frame: 2 years post treatment
To evaluate the efficacy of a reduction in dose and volume to all clinical target volumes (CTV) in patients with HPV-positive squamous cell carcinoma of the oropharynx (OPSCC) using 2-year Progression-Free Survival (PFS). Efficacy will be determined by the PFS rate at 2 years post-treatment, through continuous assessment with a boundary of 10% progression at 2 years (90% 2 year PFS).
2 years post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluated per CTCAE v6
Time Frame: Adverse events collected through 30 days post treatment and SAEs through 90 days post-treatment or until commencement of new anti-cancer therapy, whichever occurs first.
To evaluate safety by collecting adverse events per CTCAE v6 in patients who have HPV positive SCC of the oropharynx using a reduction in primary tumor and nodal CTV dose to 30 Gy.
Adverse events collected through 30 days post treatment and SAEs through 90 days post-treatment or until commencement of new anti-cancer therapy, whichever occurs first.
Quality of life measured by MDADI
Time Frame: Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT

The MDADI is a patient-reported outcome (PRO) instrument designed to assess swallowing-related quality of life in patients with head and neck cancer and dysphagia. It evaluates the functional, emotional, and physical impact of swallowing difficulties on daily life. The scale ranges from 20 - 100. Higher scores indicate better swallowing function and better swallowing-related quality of life. Lower scores indicate worse dysphagia-related quality of life

To assess the impacts on quality of life on patients who have HPV positive SCC of the oropharynx who receive a reduction in CTV dose to 30 Gy as well as a reduction in CTV volumes, via the EORTC QLQ-C30 at baseline, week 7/EOT, 6 months, 12 months 18 months and 24 months following completion of radiation therapy.
Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT
Quality of life measured by EORTC QLQ-C30
Time Frame: Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT

European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30. t is a validated patient-reported outcome (PRO) instrument designed to assess health-related quality of life (HRQoL) in patients with cancer across clinical trials and routine practice. The transformed scale ranges from 0 - 100. Functional and Global Health scales: higher = better Symptom scales/items: higher = worse

To assess the impacts on quality of life on patients who have HPV positive SCC of the oropharynx who receive a reduction in CTV dose to 30 Gy as well as a reduction in CTV volumes, via the EORTC QLQ-C30 at baseline, week 7/EOT, 6 months, 12 months 18 months and 24 months following completion of radiation therapy.
Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Medek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2026

Primary Completion (Estimated)

May 13, 2031

Study Completion (Estimated)

May 13, 2036

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCCC-RT-25-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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