NCT06759155Not yet recruitingPhase 2
Phase II Clinical Trial of De-Intensified Therapy in Human Papilloma Virus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 6 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
HPV-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) is a type of cancer that affects parts of the throat, like the tonsils and the base of the tongue. The treatments for OPSCC, which may include surgery, radiation, and chemotherapy, often cause serious side effects, such as loss of taste, dry mouth, and long-term problems with swallowing. These side effects can lower patients' quality of life and make it difficult for them to eat and speak normally. This study aims to explore whether using lower doses of radiation after surgery can help improve long-term swallowing function in patients with HPV-positive OPSCC. By doing this, the study team hopes to reduce treatment-related side effects while maintaining good cancer control.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- University of Vermont Medical Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06759155
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 1 Jan 2025 to the primary completion date, 31 Jan 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- T4 and/or T1-T3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins.
- Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
- Prior history of radiation to head and neck
Other illness
- AJCC TNM 7th edition N2c-N3 nodal disease (or AJCC TNM 8th edition N2-N3 nodal disease) or high likelihood of gross extranodal extension.
- Distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or PET CT.
Other
- HPV negative squamous cell carcinomas of the head and neck
- Women who are pregnant or breastfeeding
Who the study is looking for
- Histologically confirmed or suspected HPV associated squamous cell carcinoma of the oropharynx.
- p16 immunohistochemistry is the surrogate marker for HPV positivity and will be scored as positive if there is strong and diffuse nuclear and cytoplasmic staining present in greater than 70% of the tumor specimen. (A negative result excludes the patient from the trial)
- In the case of equivocal p16, High Risk HPV (HR HPV), In-Situ Hybridization (ISH) / Polymerase Chain Reaction (PCR) may be performed to determine HPV positivity
- AJCC TNM 7th edition stage T1-T3, N0-N2b (or AJCC TNM 8th edition stage T1-T3 N0-N1) disease.
- Staging will be based on cross sectional imaging investigations and clinical exam.
- Patients who initially have an unknown primary but subsequently have a primary site identified on pathology after surgical resection may be included in the study.
- Multidisciplinary team decision to treat with primary transoral resection and neck dissection.
- Patients considered fit for surgery and adjuvant therapy.
- Aged 18 or over.
- Written informed consent provided.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.