Status:
TERMINATED
Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Non-small Cell Lung Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ar...
Detailed Description
Primary Objectives Phase I: Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for stage II/III non-small cell lung cancer. Phase II: Two-year local co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01222572
Start Date
December 1 2010
End Date
October 1 2012
Last Update
June 4 2015
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115