Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification after Transoral Surgery for HPV-Positive Squamous Cell Carcinoma of the Oropharynx
Investigating Treatment Deintensification for HPV-Positive Oropharyngeal Cancer
Michael W. Sim, MD
Primary Investigator
Brief description of study
Detailed description of study
This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+ OPSCC who undergo transoral surgery and neck dissection.
Treatment under this protocol will be offered to patients with early-stage disease, limited to T1-3, N0-2, M0 (AJCC 8th edition). The assessments and interventions in this research study are experimental. There will be three deintensification treatment options, with subjects being directed to a particular arm depending on findings from ctHPVDNA testing and final pathology. Outcome measures will be compared to historical data (OS of 81-84% 4 and LRC of 87% 28 ) for subjects who have been treated with standard chemoradiation therapy or surgery with standard adjuvant therapy regimens, with the
potential goal of directly comparing deintensification to standard approaches in a subsequent phase III trial. The target sample size is 120 evaluable subjects. The surgical treatment will be
performed by an experienced member of Indiana University (IU) Head and Neck Surgical Oncology at University Hospital or IU North. Histopathologic analysis will be provided by the IU Department of Pathology.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Squamous Cell Carcinoma of Oropharynx, Throat Cancer, Tonsil Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
Pre-Surgery
• Subjects ≥ 18 years old at the time of informed consent.
• Ability to provide written informed consent and HIPAA authorization.
• Eastern Cooperative Oncology Group (ECOG) performance status 0–2 (refer to
Appendix).
• Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or
posterior walls of oropharynx).
• Histopathologically confirmed squamous cell carcinoma.
• Detectable ctHPVDNA from blood samples collected prior to treatment.
• Resectable and accessible tumor with high probability of achieving negative margins.
• Smokers and non-smokers included.
• Tumor stage (AJCC 8th edition): T1 or T2, and select T3 tumors that are mobile and do
not invade the larynx.
• Nodal stage (AJCC 8th edition): N0, N1 or N2.
• Mobile neck nodes on physical exam if N positive.
• HPV+ tumor, as determined by p16, in-situ hybridization, real-time polymerase chain
reaction, or ctHPVDNA.
Post-Surgery
• Subjects with unknown primaries included if primary is definitively identified and
resectable with negative margins or if the palatine and lingual tonsils are thoroughly
resected and pathologically proven to be negative for a primary.
Exclusion Criteria:
• Serious medical condition preventing general anesthesia for surgery.
• History of previous head and neck radiation or previous head and neck cancer within
3 years.
• Distant metastatic disease present.
• Subjects with synchronous HPV+ oropharynx primaries
• Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin
cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case
patient may be included in the study.
• Lactating or pregnant women. Women of childbearing potential must have a negative
pregnancy test on the day of surgery. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:
a. Has undergone a hysterectomy or bilateral oophorectomy; or
b. Has been naturally amenorrheic for at least 12 consecutive months.
This study investigates a new approach for treating HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). The purpose of this study is to see if reducing the intensity of treatment, based on levels of ctHPVDNA (pieces of cancer DNA in blood samples), can be as effective as the standard treatment. OPSCC is a type of cancer found in the throat area, and HPV is a virus that can cause this cancer.
Participants in this study will undergo surgery followed by one of three different treatment plans. These plans are determined by the ctHPVDNA levels and results from pathology tests. The study will compare these deintensified treatment options to the standard treatment, which usually involves chemotherapy and radiation. This study aims to find out if the new approach can offer similar outcomes with fewer side effects.
- Who can participate: Adults aged 18 and older with HPV-positive oropharyngeal cancer that is resectable and accessible can participate. Participants must have detectable ctHPVDNA and meet specific tumor and nodal stage criteria. Smokers and non-smokers are eligible. Participants must also have an ECOG performance status of 0 or 1.
- Study details: Participants will undergo surgery and then be assigned to one of three investigational treatment plans based on ctHPVDNA levels. A placebo is not used in this study.
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