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New treatment option for Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma...
Official title Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer
ClinicalTrials.gov ID: NCT06323460
What this study is testing
What is Carboplatin?
Carboplatin 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 Blastocarb, Carboplat.
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 studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
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 diagnosis of squamous cell carcinoma of the oropharynx (unknown primary, base of tongue, tonsil, oropharyngeal walls, soft...
- P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic tissue. If staining was done at an outside hospital, central review...
- Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on Cancer [AJCC] 8th edition) including no evidence of distant...
- Clinical or radiographic evidence of measurable disease at the primary site or lymph nodes. Simple tonsillectomy or excision of primary without...
- Fludeoxyglucose F-18 (FDG) PET/CT from the base of skull to the mid-thigh is mandatory and patients cannot be enrolled without a pretreatment PET/CT...
You likely can't join if
- Recurrent disease
- Clinical or radiographic evidence of metastatic disease or adenopathy below the clavicles
- Cancers from an oral cavity site, even if p16 positive
- Patients with simultaneous primary cancers or separate bilateral primary tumors will be excluded, except for patients with bilateral tonsil cancers
- Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
- Prior systemic chemotherapy or immunotherapy
See the full eligibility criteria
- Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx (unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate). Cytologic or fine needle aspiration (FNA) confirmation is...
- P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic tissue. If staining was done at an outside hospital, central review by the Ohio State University (OSU) department of pathology must occur...
- Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on Cancer [AJCC] 8th edition) including no evidence of distant metastases based on general history, imaging, physical examination, and...
- Clinical or radiographic evidence of measurable disease at the primary site or lymph nodes. Simple tonsillectomy or excision of primary without removal of nodal disease is permitted, as is excision of gross nodes but...
- Fludeoxyglucose F-18 (FDG) PET/CT from the base of skull to the mid-thigh is mandatory and patients cannot be enrolled without a pretreatment PET/CT. PET/CT must be completed prior to enrollment
- Pretreatment tumor tissue modified HPV virus (TTMV-HPV) particles present in plasma cell free DNA value of \>= 200 copies/mL at baseline
- Patients must provide their smoking history prior to enrollment. Patients must have =\< 10 pack years of smoking. The number of pack years will be calculated using the following formula: Frequency of smoking...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Age \>= 18
- Absolute neutrophil count: ≥ 1500/mcL (within 14 days prior to registration)
- Platelets: \>= 100,000/mcL (within 14 days prior to registration)
- Hemoglobin \>= 8.0 g/dL (use of transfusion or other intervention to achieve this is acceptable) (within 14 days prior to registration)
- Total bilirubin \>= 1.5 x institutional upper limit of normal (within 14 days prior to registration)
- Aspartate transaminase (AST) or alanine transaminase (ALT) \>= 3.0 x institutional upper limit of normal (within 14 days prior to registration)
- Serum creatinine =\ = 50 mL/min (Cockcroft-Gault Formula) (within 14 days prior to registration)
- Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
- Patients with known positive hepatitis B surface antigen indicating acute or chronic infection would make patient ineligible unless viral load becomes undetectable on suppressive therapy
- Patients with history of hepatitis C virus must have been treated and cured
- For women of childbearing potential, negative serum or urine pregnancy test within 14 days of registration
- Patient or legally authorized representative must provide study specific informed consent prior to study entry
- Recurrent disease
- Clinical or radiographic evidence of metastatic disease or adenopathy below the clavicles
- Cancers from an oral cavity site, even if p16 positive
- Patients with simultaneous primary cancers or separate bilateral primary tumors will be excluded, except for patients with bilateral tonsil cancers
- Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for a minimum of 3 years
- Prior systemic chemotherapy or immunotherapy
- Prior radiotherapy that would result in overlap of radiation fields
- Severe active co-morbidity defined as: Unstable angina or congestive heart failure requiring hospitalization in the last 6 months. Condition requiring systemic treatment with steroids or immunosuppressive medications...
- Patients with active autoimmune disease requiring systemic treatment (disease modifying agents, corticosteroids, or immunosuppressive drugs
- Patients who are pregnant, nursing, or expected to conceive or father children
- Patients who are allergic to cisplatin, carboplatin, or paclitaxel
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, 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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Columbus, Ohio, 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.