Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer, Lung Cancer, NSCLC

In brief

In this research study the investigators are looking for the highest dose of a stereotactic radiation boost that can be given safely. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects the participant experiences; the goal is to improve the likelihood of killing the tumor.

Key facts

Study ID

NCT01222572

Run by

Dana-Farber Cancer Institute

People needed

1

Starts

2010-12-01

Expected to finish

2012-10-01

Last updated by the study team

2015-06-04

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed stage II or stage III non-small cell lung cancer, or stage IV non-small cell lung cancer that will be treated with curative intent
• Evaluated by a surgeon and deemed inoperable
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 10mm or greater with chest CT scan.
• No active malignancy within the past 5 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix
• 18 years or older
• Life expectancy of greater then 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Normal organ and marrow function as outlined in the protocol
• Forced expiratory volume (FEV1) of 1 L or greater OR 50% or greater of predicted

You may not qualify if…

• Primary tumor size greater then 6cm
• Prior history of thoracic radiotherapy
• May not be receiving any other study agents
• History of pulmonary fibrosis
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide
• Primary tumor < 1.5 cm beyond hilar lymphadenopathy (if any) and 1.5 cm from proximal bronchial tree, defined as the trachea, right and left mainstem bronchus, and lobar bronchi until the 1st lobar segment
• Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breast feeding women
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
• Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy
• Patients who are planned to receive the following medication: granulocyte colony-stimulating factor (G-CSF), bevacizumab, cetuximab, cyclosporine, anti-tumor necrosis factor agents, amifostine.

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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