Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer

Stopped early · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT01565772

Run by

Massachusetts General Hospital

People needed

4

Starts

2012-03-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-small cell lung cancer with a clinical stage of IIIA
• Candidate for chemoradiation and surgical resection
• Measurable disease
• Life expectancy > 6 months
• Normal organ and marrow function

You may not qualify if…

• Pregnant or breast-feeding
• Prior therapy for lung cancer with chemotherapy
• Prior chest radiation
• Compromised pulmonary function
• Severe neurovascular disease
• History of high cardiac risk including unstable angina
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, clinically significant or serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• History of a different malignancy unless disease-free for at least 3 years and at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, non muscle-invasive bladder cancer, basal cell or squamous cell carcinoma of the skin
• Subjects with HIV

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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