NCT03875716 Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma
| NCT ID | NCT03875716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 111 participants |
| Start Date | 2019-05-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 111 participants in total. It began in 2019-05-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 cigarettes. * 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. Exclusion Criteria: * 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 that would limit compliance with study requirements. Note: that HIV positive patients will be eligible. * 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 to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.
Contact & Investigator
Danielle N. Margalit, MD, MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT03875716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03875716 currently recruiting?
Yes, NCT03875716 is actively recruiting participants. Contact the research team at danielle_margalit@dfci.harvard.edu for enrollment information.
Where is the NCT03875716 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03875716 clinical trial?
NCT03875716 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Danielle N. Margalit, MD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 111 participants.
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