Phase II Clinical Trial of De-Intensified Therapy in Human Papilloma Virus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: de-intensified radiation.
- Who it may be relevant to
- Registry conditions: OPSCC, Oropharyngeal Squamous Cell Carcinoma (SCC), HPV Associated Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation de-intensified radiation
Adjuvant radiation will be administered on a de-intensified schedule.
Primary outcome measures
- Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring overall survival. [Time frame: from enrollment to 5 year follow-up]
- Safety and tolerability [Time frame: from enrollment to 5 year follow-up]
- Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring progression free survival. [Time frame: from enrollment to 5 year follow-up]
- Assess oncologic outcomes of a de-intensified post-surgical adjuvant treatment by measuring locoregional control. [Time frame: from enrollment to 5 year follow-up]
Secondary outcome measures (1)
- Evaluate how changes in serum HPV ctDNA are associated\ with HPV-positive OPSCC recurrence [Time frame: from enrollment to 5 year follow-up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- HPV negative squamous cell carcinomas of the head and neck
- T4 and/or T1-T3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins.
- AJCC TNM 7th edition N2c-N3 nodal disease (or AJCC TNM 8th edition N2-N3 nodal disease) or high likelihood of gross extranodal extension.
- Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.
- Distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or PET CT.
- Women who are pregnant or breastfeeding
- Prior history of radiation to head and neck
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06759155 · STUDY00003257/UVMCC2405