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

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Etoposide; Etoposide phosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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