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New treatment option for Oropharynx Cancer
Official title Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer
ClinicalTrials.gov ID: NCT05800574
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for oropharynx cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.
- Phase 2: a mid-size study of how well it works
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
- Pathologically confirmed squamous cell carcinoma of the oropharynx
- Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below):
- Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\> 1...
- Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and/or by the treating radiation oncologist...
- CT with contrast and/or MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the...
You likely can't join if
- Tumors that cross midline, regardless of T stage
- N2 adenopathy (bilateral neck adenopathy)
- Gross total excision of the primary site in a diagnostic procedure prior to either imaging and/or physical examination by registering physician.
- p16-negative squamous cell carcinoma
- Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
- Prior systemic therapy for the study cancer
See the full eligibility criteria
- Pathologically confirmed squamous cell carcinoma of the oropharynx
- Patients to be treated with bilateral neck radiation per current guidelines must have either present (see below):
- Nodal status (based on staging manual, AJCC (American Joint Committee on Cancer) 8th ed.): N0 (provided the tumor is within 1cm of midline) N1\> 1 lymph nodes (on the same side of the neck as the primary cancer) or cN3...
- Tumor stage T1-2 that approaches within 1 cm but does not cross midline as appreciated radiographically and/or by the treating radiation oncologist or a head and neck surgeon
- CT with contrast and/or MRI with contrast performed within 56 days prior to registration that does not demonstrate bilateral neck adenopathy. In the setting of medical contraindication to both CT and MRI contrast please...
- PET/CT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy.
- Immunohistochemical staining for p16 that demonstrates moderate to severe staining in at least 70% of cells.
- Patients must provide their smoking history prior to registration. Number of pack-years = [Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)]/20
- Patients must have clinically and/or radiographically evident disease that can be accurately measured in accordance with RECIST criteria v. 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 56 days prior to registration
- Age ≥ 18 years.
- Adequate hematologic function within 14 days prior to registration
- Adequate renal function within 14 days prior to registration
- Adequate hepatic function within 14 days prior to registration
- Tumors that cross midline, regardless of T stage
- N2 adenopathy (bilateral neck adenopathy)
- Gross total excision of the primary site in a diagnostic procedure prior to either imaging and/or physical examination by registering physician.
- p16-negative squamous cell carcinoma
- Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
- Prior systemic therapy for the study cancer
- Prior head and neck cancer surgery that involved the neck (includes excisional biopsy)
- Prior radiation therapy to the head and neck that would result in overlap of treated fields
- History of allergic reaction attributed to Technetium-99m-tilmanocept used in lymphoscintigraphy
- Uncontrolled intercurrent illness including, but not limited to, any other malignancy, other ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or...
- Pregnant or breast feeding
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 Philadelphia, Pennsylvania, 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.