Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer
NCT01958372 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2020-11-23
Summary
This phase I trial studies the side effects of soy isoflavones when given together with radiation therapy and chemotherapy in treating patients with stage IIIA-IIIB non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, pemetrexed sodium, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Soy isoflavones may help radiation therapy, cisplatin, pemetrexed sodium, and etoposide work better by making tumor cells more sensitive to the drug. Soy isoflavones may also protect normal cells from the side effects of radiation therapy and chemotherapy.
Conditions
- Adenocarcinoma of the Lung
- Adenosquamous Cell Lung Cancer
- Bronchoalveolar Cell Lung Cancer
- Large Cell Lung Cancer
- Recurrent Non-small Cell Lung Cancer
- Squamous Cell Lung Cancer
- Stage IIIA Non-small Cell Lung Cancer
- Stage IIIB Non-small Cell Lung Cancer
Interventions
- DIETARY_SUPPLEMENT
-
soy isoflavones
Given PO
- DRUG
-
Given IV
- DRUG
-
etoposide
Given IV
- DRUG
-
pemetrexed disodium
Given IV
- RADIATION
-
radiation therapy
Undergo RT
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Barbara Ann Karmanos Cancer Institute
lead OTHER
Principal Investigators
-
Shirish Gadgeel · Barbara Ann Karmanos Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2017-10-09
- Completion
- 2019-11-11
Countries
- United States
Study Locations
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