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New treatment option for Squamous Cell Carcinoma of Oropharynx
Official title ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx
ClinicalTrials.gov ID: NCT06915038
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre-Surgery
- people ≥ 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.
- Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
You likely can't join if
- 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.
- people 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...
- Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test on the day of surgery. Women are considered to have...
See the full eligibility criteria
- Pre-Surgery
- people ≥ 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.
- 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
- people 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...
- 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.
- people 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...
- Has undergone a hysterectomy or bilateral oophorectomy; or
- Has been naturally amenorrheic for at least 12 consecutive months.
The study team makes the final eligibility decision.
Where it's taking place
- Carmel, Indiana, United States
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carmel, Indiana, United States; Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.