Study on Reducing Radiation Doses in HPV-Related Oropharyngeal Cancer to Minimize Side Effects
Sponsor: University of Maryland, Baltimore
ClinicalTrials ID:NCT07418034
This clinical trial is exploring whether lowering radiation doses can reduce side effects while still effectively controlling HPV-related oropharyngeal cancer. The study focuses on patients who receive either surgery followed by radiation or radiation as their first treatment.
Patient Parameters
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Program Overview
Patients with HPV-related oropharyngeal cancer usually have good outcomes, but treatments can cause significant side effects. This study aims to see if reducing radiation doses can lessen these side effects without compromising cancer control. For patients who have surgery first, the study will test if lowering radiation to low-risk lymph nodes on the neck's opposite side can reduce side effects (Method A). For those receiving radiation first, the study will test two approaches: reduced lymph node radiation (Method A) and reduced tumor radiation (Method B). Eligibility for these methods depends on cancer characteristics and risk factors. A blood test called ctDNA will help determine if patients can safely receive lower tumor radiation (Method B).
Description
This study is for people with HPV-related head and neck cancer who are treated with either surgery followed by radiation or radiation as their first treatment. While patients generally have excellent outcomes, treatments can cause significant side effects. This research focuses on whether radiation doses can be safely reduced to lessen these side effects while still effectively controlling the cancer.
Patients typically receive either surgery or radiation as their initial treatment. For those who have surgery first, radiation is often recommended afterward to the surgical area and nearby neck lymph nodes. Traditionally, this includes radiation to lymph nodes on both sides of the neck, even the side opposite the tumor. This study will evaluate if lowering the radiation dose to low-risk lymph nodes on the opposite side can reduce side effects without compromising cancer control (Method A).
For patients receiving radiation first, the study will evaluate one or two radiation-reduction strategies. Besides reduced lymph node radiation (Method A), the study will also examine tumor dose reduction (Method B), which lowers the radiation delivered directly to the tumor. Eligibility for these approaches is based on cancer characteristics, such as tumor size, number of involved lymph nodes, and risk factors like smoking history.
For those who may qualify for tumor dose reduction (Method B), an additional blood test called a circulating tumor DNA (ctDNA) test is used. This test measures small amounts of tumor DNA in the blood. Studies suggest that patients whose ctDNA levels are negative after treatment are less likely to have their cancer return. In this study, ctDNA testing before and during radiation will help identify patients who may safely stop radiation earlier than usual (Method B).
Participants are followed closely as part of their routine cancer care, including regular clinic visits, imaging, and physical exams. This also includes research procedures like questionnaires about symptoms and quality of life. Some participants will provide additional blood samples to help researchers understand which factors may predict treatment response and long-term outcomes.
Up to 132 patients will participate in this study at the University of Maryland Medical System. Participation is voluntary, and treatment decisions, such as whether to have surgery or radiation and whether to receive chemotherapy, are made by the patient and their medical team, not determined by the study. However, the study procedures will determine participants' eligibility for and use of one or both radiation reduction approaches.
The goal is to improve future care by finding safe ways to reduce radiation and treatment-related side effects while maintaining excellent cancer control.
Eligibility Criteria
4.1 Step 1 Registration 4.1.1 Step 1 Inclusion
(Y) 1. Is there pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.
(Y) 2. Is the patient ≥ 18 years of age?
(Y) 3. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?
(Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):
TORS candidate patients must be:
• cT0-4 and N0, N1, N3
Non-TORS candidate patients must be either:
- cT1-4 N0, N1, N3
- cT1-3 N2 with < 10 pack years
4.1.2 Step 1 Exclusion
(N) 1. Patient who are clinical N2 and have ≥10 pack years smoking history
(N) 2. Patients who are clinical T4N2
(N) 3. Patients with distant metastasis (M1)
4.2 Step 2 Registration 4.2.1 Step 2 inclusion
(Y) 1. Does the patient have pathologically (histologically or cytologically) proven P16+ status?
(Y) 2. Does the patient have appropriate imaging (PET/CT preferred, CT neck with IV contrast and CT chest without contrast as recommended alternative to PET/CT) completed within 90 days of enrollment?
(Y) 3. Does the patient have clinical or pathological M0 staging? (Y) 4. Patients who have undergone TORS must have pathological stage pT1-4 N0, N1 or N3. TORS patients found to be clinical N2 post TORS or have contralteral neck dissection and positive nodes will be excluded.
(Y) 5. Is the patient a candidate for bilateral radiation based on evaluation by ENT, Rad Onc, or Med Onc and review at multi-disciplinary tumor board?
(Y) 6. Non-TORS patients who are cT1-3 N0, N1, N2 and have <10 PY must have completed a ctDNA evaluation prior to Step 2 enrollment.
(Y) 7. Non-TORS patients who are cT1-3 N2 must have a positive ctDNA result prior to Step 2 enrollment.
(Y) 8. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?
(Y) 9. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?
(Y) 10. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.
4.2.2 Step 2 Exclusion
(N) 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?
(N) 2. Does the patient have distant metastasis?
(N) 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low/intermediate risk prostate cancer) unless disease free for a minimum of 3 years?
(N) 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?
(N) 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?
(N) 6. Did the patient have prior cancer-related surgeries of curative intent of the head and neck excluding superficial removal of cutaneous skin malignancies?
(N) 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?
(N) 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?
(N) 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Maryland Proton Treatment Center | 21201 | Baltimore | Maryland |
| University of Maryland Greenebaum Cancer Center | 21201 | Baltimore | Maryland |
| Central Maryland Radiation Oncology | 21044 | Columbia | Maryland |
| Baltimore Washington Medical Center- Tate Cancer Center | 21061 | Glen Burnie | Maryland |
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