Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

July 2, 2021

Primary Completion Date

June 1, 2030

Study Completion Date

June 1, 2032

Conditions
HPV-Associated Oropharyngeal Squamous Cell CarcinomaHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 StageHPV-Related Squamous Cell CarcinomaClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8HPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Clinical StageHPV-Mediated (P16-Positive) Oropharyngeal Carcinoma by AJCC V8 Pathologic Stage
Interventions
DEVICE

NavDx HPV ctDNA Testing

Blood will be collected and shared with an outside lab for analysis. This test will be done at Week 4 and at End of Treatment. This test will be done at at End of Treatment and in follow-up at 3, 6, 9, and 12 months after completing the study treatment. In years 2 and 3 after treatment, the test will be collected every 6 months or twice a year. The specimens will be identifiable. The specimens will be banked for future use.

RADIATION

Radiotherapy

Radiation Therapy (administered daily, Monday-Friday). Higher risk participants will receive standard radiation dose for up to 7-8 weeks. Lower risk participants will receive a lower dose and treatment will only last 5-6 weeks.

DRUG

Chemotherapy drug

"Chemotherapy and radiation therapy are both considered standard treatments~* Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses.~* Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy."

Trial Locations (2)

02115

RECRUITING

Brigham and Women's Hospital, Boston

02215

RECRUITING

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Naveris

UNKNOWN

lead

Jonathan Schoenfeld, MD, MPH

OTHER

NCT04900623 - Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study | Biotech Hunter | Biotech Hunter