No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
31 (estimated)
Sponsor
Sara Medek · Other
Who this trial is looking for
This trial is looking for adults with HPV positive oropharyngeal cancer. Participants will receive a lower dose of radiation while undergoing treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with oropharyngeal squamous cell carcinoma.
I am at least 18 years old.
I have measurable disease based on recent imaging.
I have a specific type of oropharyngeal cancer that is p16 positive.
I can understand and sign a consent form.
I am eligible for standard chemotherapy with cisplatin.
I am in good enough health to participate.
You may not be able to join if
I have metastatic or recurrent cancer.
I have a neck cancer with an unknown primary site.
I have received prior radiation therapy that overlaps with the new treatment area.
I am pregnant, nursing, or planning to have children during the study.
I have an active autoimmune disease that requires treatment.
I am taking any other investigational drugs.
I have any serious health condition that could make participation risky.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 immunohistochemi…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.