Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

September 30, 2019

Study Completion Date

September 30, 2019

Conditions
Cancer of Head and Neck
Interventions
DRUG

Soy isoflavone

Patients will receive genistein 150 mg daily for the duration of radiation treatment. If a patient is experiencing significant side effects attributable to genistein, the treating physician has the option to reduce genistein to 150 mg every other day.

RADIATION

Radiation

All patients will undergo computed tomography (CT) simulation with intravenous (IV) contrast unless medical contraindications to IV contrast exist. Gross disease will be treated to 70 Gy in 2 Gy/day.

DRUG

Cisplatin

Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.

Trial Locations (2)

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Winship Cancer Institute, Atlanta

All Listed Sponsors
collaborator

Radiation Therapy Oncology Group

NETWORK

lead

Emory University

OTHER

NCT02075112 - Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck | Biotech Hunter | Biotech Hunter