Oropharyngeal Squamous Cell CarcinomaPhase 2REDUCE-30NCT07497607
Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Cisplatin and Radiotherapy in people with Oropharyngeal Squamous Cell Carcinoma and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Sara Medek at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Cisplatin and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 13 May 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Medek, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Sara Medek, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Cisplatin, Radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
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.
RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Elective Nodal and CTV Dose | Experimental | Reduction in primary tumor and nodal CTV dose to 30 Gy. Receives: Drug: Cisplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years post treatment
Secondary outcomes (3)
Safety evaluated per CTCAE v6
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start13 May 2026
- Primary completion13 May 2031 (estimated)
- Study completion13 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Medek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Medek, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497607
- Sponsor's protocol ID
- UCCC-RT-25-03
- Acronym
- REDUCE-30
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)
- ClinicalTrials.gov ID
- NCT07497607
- Acronym / sponsor ID
- REDUCE-30 / UCCC-RT-25-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Sara MedekUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 13 May 2031 (estimated)
- Study completion
- 13 May 2036 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm
| Arm | Type | Receives |
|---|---|---|
| Reduced Elective Nodal and CTV Dose | Experimental | Drug: Cisplatin, Radiation: RadiotherapyReduction in primary tumor and nodal CTV dose to 30 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinSubjects 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. | Drug | Reduced Elective Nodal and CTV Dose |
| RadiotherapyRadiotherapy 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. | Radiation | Reduced Elective Nodal and CTV Dose |
Primary outcome
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).
3 secondary outcomes
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Medek, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and Radiotherapy in people with Oropharyngeal Squamous Cell Carcinoma and HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Sara Medek at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS) (time frame: 2 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.