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New treatment option for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma...
Official title De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA
ClinicalTrials.gov ID: NCT05541016
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Also referred to as Abiplatin, Blastolem.
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 phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy.
- 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
- PRE-REGISTRATION (optional): Provide written informed consent
- Age \>= 18 years
- Histological confirmation of squamous cell carcinoma originating from or suspected to be originating from the oropharynx
- Plan for gross total surgical resection via trans oral surgery with curative intent and at least unilateral neck dissection OR chemoradiotherapy with...
- Absence of distant metastases on standard diagnostic work-up =\< 16 weeks prior to registration. (Chest CT or PET/CT)
You likely can't join if
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for...
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)+
See the full eligibility criteria
- PRE-REGISTRATION (optional): Provide written informed consent
- Age \>= 18 years
- Histological confirmation of squamous cell carcinoma originating from or suspected to be originating from the oropharynx
- Plan for gross total surgical resection via trans oral surgery with curative intent and at least unilateral neck dissection OR chemoradiotherapy with cisplatin. Note: The patient must be cisplatin eligible even if an...
- Absence of distant metastases on standard diagnostic work-up =\< 16 weeks prior to registration. (Chest CT or PET/CT)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 1
- Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
- Ability to complete questionnaire(s) by themselves or with assistance
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willing to provide blood samples for correlative research purposes, including anonymous shipment of samples to for NavDx testing
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper...
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)+
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Other active malignancy =\< 5 years prior to registration. EXCEPTIONS: Nonmelanotic skin cancer or carcinoma-in-situ of the cervix, or prostate or localized endometrioid endometrial cancer. NOTE: If there is a history...
- Prior history of radiation therapy to the affected site
- Prior systemic chemotherapy in the last 5 years
- Contraindication to radiation therapy as determined by the treating team
- History of allergic reaction to docetaxel
- Receiving any medications or substances which in the opinion of the investigators would interfere with treatment. Examples could include strong inhibitors of cytochrome P450 3A4 (CYP3A4) at oncologist discretion
- Severe pre-existing ototoxicity or neuropathy that would, in the opinion of the investigator, preclude the use of cisplatin chemotherapy
- cT4 primary tumor
- NOTE: Patients with no intermediate risk factors after surgery, low risk patients, as defined by T1, T2, tumors with lymph node less than 3cm, no intermediate or high-risk factors such as lymphatic invasion (LVSI)...
- Patients found to have HPV non 16 type, or HPV detectability in blood less than \<20tumor tissue modified viral (TTMV) will not be candidates for de-escalation in Groups 1 and 2 and will be treated in Group 3 unless...
- Patients with unknown (radiologic/clinically occult) primaries but neck adenopathy suspected to be HPV associated oropharyngeal carcinoma can be registered to go on study for Groups 1-3. Should after primary resection...
- All treatment primarily, including surgery and chemotherapy will be performed at the enrolling institution
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, 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.