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New treatment option for Head and Neck Cancer
Official title Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT03875716
What this study is testing
- What it's testing
- This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.
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
- Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive...
- HPV-associated tumor as defined by: positive p16 immunohistochemistry (\>70%) OR in situ hybridization OR PCR-based methods
- Eligible for curative-intent surgery with anticipated negative margins
- Surgery performed at Brigham \& Women's Hospital
- Age 18 or older years.
You likely can't join if
- Prior history of head and neck cancer within 5 years.
- Prior head and neck radiation
- Clinically fixed or matted nodes
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an...
See the full eligibility criteria
- Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases
- HPV-associated tumor as defined by: positive p16 immunohistochemistry (\>70%) OR in situ hybridization OR PCR-based methods
- Eligible for curative-intent surgery with anticipated negative margins
- Surgery performed at Brigham \& Women's Hospital
- Age 18 or older years.
- ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A)
- Normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,000/mcL
- platelets ≥100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine ≤ 1.5 times the institutional upper limit of normal OR
- creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Patients with ≤20 pack-years of cumulative cigarette smoking. Pack-years are calculated by multiplying the number of years smoked with the pack of cigarettes smoked per day. One pack is considered to contain 20...
- Tumor clinical stage (AJCC 8th edition): T0 or T1 or T2
- Nodal clinical stage (AJCC 8th edition): N0 or N1
- No distant metastases. Clinical M-stage must be M0 (AJCC 8th edition).
- Ability to understand and the willingness to sign a written informed consent document.
- Prior history of head and neck cancer within 5 years.
- Prior head and neck radiation
- Clinically fixed or matted nodes
- 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...
- Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 Boston, Massachusetts, 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.