Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck
NCT ID: NCT02075112
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2013-11-30
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Soy isoflavone
Study treatment: Soy isoflavone in combination with radiation therapy \& cisplatin
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
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.
Cisplatin
Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.
Interventions
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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
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.
Cisplatin
Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary disease site involving the oropharynx
* Clinical stage III or IV
* Age ≥ 18
* Karnofsky Performance Status (KPS) ≥ 70
* Adequate bone marrow, kidney, and hepatic function (no laboratory value \> 2 times the normal limit)
* Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal
Exclusion Criteria
* Prior history of radiation to the head and neck region
* KPS \< 70
* Soy allergy
* Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy
* Any head and neck cancer of non-squamous histology
* Any head and neck subsite other than oropharynx (including unknown primary site)
* Patients who are pregnant or lactating
* Patients who may benefit from surgical resection
18 Years
ALL
No
Sponsors
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Radiation Therapy Oncology Group
NETWORK
Emory University
OTHER
Responsible Party
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Kristin Higgins, MD
Principal Investigator
Principal Investigators
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Kristin Higgins, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Other Identifiers
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RAD2412-13
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00065591
Identifier Type: -
Identifier Source: org_study_id
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