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Brief Title: Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
Official Title: A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
Study ID: NCT01565772
Brief Summary: This research study is looking at an alternative way of delivering radiation therapy with protons. Protons are tiny particles with a positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Information from other research studies suggests that proton radiation may help to reduce unwanted side effects from radiation and allow an increase in radiation dose that increase the odds of tumor killing. The purpose of this study is to determine the safest dose of proton radiation therapy to give in combination with standard chemotherapy in participants with Non-Small Cell Lung Cancer (NSCLC).
Detailed Description: Proton radiation will be delivered daily Monday through Friday for 5 weeks. Study therapy will be give as an outpatient at the Francis H. Burr Proton Center at Massachusetts General Hospital. During the weeks that subjects receive radiation, they will also receive 2 cycles of chemotherapy. Each cycle will last 28 days. Cisplatin will be give as an IV infusion over 30-60 minutes or 1-2 hours on Days 1 and 8 of Cycles 1 and 2. Etoposide will be given as an IV infusion over 60 minutes on Days 1, 2, 3, 4, 5 of Cycles 1 and 2. After radiation and 2 cycles of chemotherapy are completed, subjects may have surgery to remove their tumor. Following surgery, subjects may receive another 2 cycles of chemotherapy (Cycles 3 and 4). Each cycles lasts 21 days. Cisplatin is given on Day 1. Etoposide is given on Days 1, 2, and 3.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital, Boston, Massachusetts, United States
Name: Henning Willers, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR