Squamous Cell Carcinoma of the Oropharynx study: Radiation Therapy
Official title HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT05962242
What this study is testing
- What it's testing
- This study checks if using less radiation than usual is safe and effective for treating throat cancer.
- Who it's for
- People with squamous cell carcinoma of the oropharynx (the back part of the throat).
- What's involved
- Participants will receive a lower-than-standard dose of radiation to treat their cancer.
- Time commitment
- The source text does not specify the duration or visit schedule.
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ≥ 18 years of age
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx of any AJCC 8th edition stage.
- Eligible for and planning to receive definitive treatment or adjuvant treatment with radiotherapy.
You likely can't join if
- Evidence of distant metastatic disease
- Prior history of radiotherapy to the head and/or neck
- Had surgery for oropharyngeal cancer within 8 months of enrollment unless it was an incomplete oncologic surgery.
- Diagnosis of T3-4 and/or N+ disease with no plans to receive concurrent chemotherapy.
- Diagnosis of a current or prior invasive malignancy (except non-melanoma skin cancer) unless the participant has been disease free for at least 3...
- Participant is a prisoner
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, ≥ 18 years of age
- Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx of any AJCC 8th edition stage.
- Eligible for and planning to receive definitive treatment or adjuvant treatment with radiotherapy.
- Participants who are receiving concurrent systemic anticancer therapy (e.g. chemotherapy or immunotherapy) for oropharyngeal cancer are eligible.
- For participants with T1-2 and N0 disease, chemotherapy is not required for eligibility. Participants may or may not receive chemotherapy per physician discretion.
- For participants with T3-4 and/or N+ disease, chemotherapy is required for eligibility.
- Participants may receive investigational agents with prior approval from the Principal Investigator.
- ECOG Performance Status of 0-2.
- p16 positive HPV as determined by NavDx and immunohistochemistry
- For females of reproductive potential: agreement to use adequate contraception during radiation treatment and for 6 months (or more if applicable based on other medications) after the end of radiation treatment.
- Evidence of distant metastatic disease
- Prior history of radiotherapy to the head and/or neck
- Had surgery for oropharyngeal cancer within 8 months of enrollment unless it was an incomplete oncologic surgery. Participant is eligible if the gross tumor was not completely removed.
- Diagnosis of T3-4 and/or N+ disease with no plans to receive concurrent chemotherapy.
- Diagnosis of a current or prior invasive malignancy (except non-melanoma skin cancer) unless the participant has been disease free for at least 3 years.
- Participant is a prisoner
- Known contraindications to head and neck radiation therapy such as ataxia telangiectasia or scleroderma.
- Pregnancy or lactation
- Unstable angina and/or congestive heart failure requiring hospitalization up to 180 days before registration
- Transmural myocardial infarction up to 180 days before registration
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency as determined by the treating clinician resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction.
- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly...
- Tobacco smoking history of 10 pack years or greater, or ≥ 20 pack years if smoking cessation occurred at least 1 year prior to enrollment
- Current use of antineoplastic drugs for other malignancies.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, 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 Miami, Florida, United States; Charlottesville, Virginia, United States; Richmond, Virginia, 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.