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Compares treatment options for HPV-Related Squamous Cell Carcinoma
Official title A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
ClinicalTrials.gov ID: NCT06563479
What this study is testing
What is Chemoradiation?
Chemoradiation is an investigational medicine, being studied as a potential treatment for hpv-related squamous cell carcinoma.
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 researchers are doing this study to find out if a personalized approach to chemoradiation therapy (which may include a lower dose of radiation) is as effective as the standard chemoradiation therapy in people with HPV-positive throat cancer. Other purposes of this study include looking at the following: Whether a lower dose of radiation in combination with standard chemotherapy causes fewer side effects than the standard dose of radiation therapy in combination with standard chemotherapy How the study approaches (lower dose of radiation therapy + standard chemotherapy and standard dose of radiation therapy + standard chemotherapy) affect participants' quality of life.
- Phase 3: a large, late-stage study
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 (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of...
- Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ...
- Clinical stage Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
- ECOG Performance Status of 0-1 or KPS \>/=70
- Age ≥ 18
You likely can't join if
- Patients with prior head and neck radiation therapy where there is \>30% overlap with the current head and neck radiation fields. Exceptions can be...
- Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue
- Patients with simultaneous primary cancers outside of the oropharynx o Note: Exceptions can be made for patients with simultaneous primaries outside...
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90%...
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- No particle therapy
See the full eligibility criteria
- Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) or squamous cell carcinoma with an unknown...
- Patients must test positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization (RNAscope® 2.5 HD Reagent kit (Advanced Cell Diagnostics, Inc...
- Clinical stage Tx-2, N1-2c (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT.
- ECOG Performance Status of 0-1 or KPS \>/=70
- Age ≥ 18
- Adequate hematologic function within 30 days prior to registration, defined as follows:
- White Blood Count (WBC) ≥ 2 K/mcL
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 10.0 g/dl
- Adequate renal function within 30 days prior to registration, defined as follows: o Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault...
- Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
- The patient must provide study-specific informed consent prior to study entry
- Optional section of the protocol: Patients must be able to undergo MRI scans, i.e. not claustrophobic
- Patients with prior head and neck radiation therapy where there is \>30% overlap with the current head and neck radiation fields. Exceptions can be made if determined by the PI/Co-PI that the patient can proceed with...
- Patients whose tumors are borderline T4 based on anterior tumor extension to the extrinsic muscles of the tongue
- Patients with simultaneous primary cancers outside of the oropharynx o Note: Exceptions can be made for patients with simultaneous primaries outside the oropharynx if determined by the PI/Co-PI the patient can proceed...
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years to be 90% or greater o Note: Exceptions can be made for patients with prior...
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- No particle therapy
- Patients who are deemed non-compliant to all the protocol related activities
- Contraindications to receive either cisplatin or the combination of carboplatin/5-fluorouracil at the prescribed doses.
- Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- 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 within 30 days of registration
- Hepatic Insufficiency resulting in clinical jaundice and/or coagulation defects
The study team makes the final eligibility decision.
Where it's taking place
- Hartford, Connecticut, United States
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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 Hartford, Connecticut, United States; Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 3 more location(s). 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.