Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma

NCT07497607 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UCCC-RT-25-03
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oropharyngeal Squamous Cell Carcinoma; HPV Positive Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS)

  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 Outcomes (3)

• Safety evaluated per CTCAE v6

  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

  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

  Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT

Study Arms (1)

Reduced Elective Nodal and CTV Dose

EXPERIMENTAL

Reduction in primary tumor and nodal CTV dose to 30 Gy.

Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Cisplatin DRUG

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.

Reduced Elective Nodal and CTV Dose

Radiotherapy RADIATION

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.

Reduced Elective Nodal and CTV Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.
• Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.
• OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.
• Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation.
• Age ≥18 years.
• ECOG performance status ≤2.
• Patients must be deemed eligible for planned SOC cisplatin per treating investigators and/or treating medical oncologist.
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• \. Patients with metastatic or recurrent disease.
• \. Carcinoma of the neck of unknown primary site origin (T0 is ineligible even if p16 is positive).
• \. Prior radiotherapy resulting in overlap of radiation therapy fields.
• \. Patients who are pregnant, nursing or intended to conceive or father children during the course of the study.
• \. Patients with active autoimmune or connective tissue disease that require systemic treatment in the opinion of the Investigator.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Sara Medek: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Central Study Contacts

UCCC Clinical Trials Office

CONTACT

513-584-7698; cancer@uchealth.com

Sara Medek, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-arm

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): May 13, 2031
• Study Completion (Estimated): May 13, 2036
• Last Updated: May 18, 2026

Record last verified: 2026-03

Locations

US (1)