Lowering radiation and chemotherapy after surgery for HPV-related throat cancer
A Phase 2 Study of De-Intensified Risk-Adapted Postoperative Radiation Therapy for Human Papilloma Virus Associated Oropharyngeal Squamous Cell Carcinoma: the ADAPT Trial
This study is testing if giving less radiation and chemotherapy after surgery can still effectively treat people with HPV-related throat cancer while reducing side effects and improving their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03875716 on ClinicalTrials.gov |
What this trial studies
This research focuses on evaluating the effectiveness of reduced intensity postoperative treatments for patients with HPV-associated oropharyngeal squamous cell carcinoma. The study aims to determine if less radiation or chemotherapy can be safely administered after surgery while still maintaining high cure rates. By minimizing treatment intensity, the investigators hope to reduce side effects and improve the overall quality of life for patients recovering from head and neck cancer. The approach includes alternatives like surveillance instead of radiation, aiming for a balance between effective cancer control and patient comfort.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed HPV-positive oropharyngeal squamous cell carcinoma who have undergone curative-intent surgery.
Not a fit: Patients with non-HPV-related head and neck cancers or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related side effects for patients with HPV-associated throat cancer.
How similar studies have performed: Other studies have shown promise in reducing treatment intensity for HPV-related cancers, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Danielle N. Margalit, MD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Danielle N. Margalit, MD, MPH
- Email: danielle_margalit@dfci.harvard.edu
- Phone: 617-632-3591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.