Oropharynx Cancer study: Radiation therapy vs Cisplatin
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?
An investigational once‑weekly injectable medicine being studied for treating p16+ oropharynx cancer. Cisplatin is designed to damage DNA in cancer cells, preventing them from dividing.
Also referred to as Cisplatin.
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
- The study aims to see if using lymphoscintigraphy to direct elective neck radiation is effective for patients with favorable‑risk p16+ oropharynx cancer.
- Who it's for
- It is for adults with p16+ oropharynx cancer who have either no neck nodes or only malignant nodes on the same side of the neck as the tumor.
- What's involved
- Participants will undergo a lymphoscintigraphy scan to map neck nodes and then receive targeted neck radiation based on the scan results. They will have scheduled visits for the scan, treatment planning, and radiation sessions.
- 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
- 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.
- PET/CT performed with 28 days prior to registration that does not demonstrate bilateral neck adenopathy.
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
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.