Status:
TERMINATED
Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
University of Miami
Conditions:
Non-Small Cell Lung Cancer
NSCLC
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fract...
Detailed Description
Paarticipants will receive a single fraction of LEAD radiation on day 1, followed one day later by conventionally fractionated concurrent chemoradiation consisting of 60 Gy of radiation delivered to i...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically documented stage III non-small cell lung cancer including squamous cell, adenocarcinoma, large cell carcinoma and poorly differentiated non-small cell lung cancer.
- Patients must have a minimum of 4 cm of measurable disease in any one continuous dimension as seen on diagnostic CT scan.
- Pulmonary function tests with forced expiratory volume in 1 second (FEV1) ≥1.45 liters/second.
- Patients must be 21 years of age or older. There is no maximum age restriction.
- Patients must have a Zubrod performance status of 0 or 1.
- Patients must have normal organ and marrow function as defined below:
- leukocyte \> 3,000/:I
- absolute neutrophil count \>1,500/:I
- platelets \>100,000/:I
- bilirubin within normal institutional limits
- Aspartate transaminase (AST/SGOT)/Alanine transaminase (ALT/SGPT) 2.5 X institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
- Patients must have weight loss ≤ 10% over the past three months.
- Women of child-bearing potential and men will be asked to use adequate contraception.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients may not have had prior thoracic radiation at any time, or prior chemotherapy for the study cancer at any time.
- Patients may not be receiving any other investigational agents for the study cancer.
- Patients may not have evidence of brain metastases on baseline CT scan or MRI.
- Patients may not have measurable gross disease in the thorax \<4 cm in any one continuous dimension.
- Patients may not have a cytologically positive pleural effusion.
- Patients may not have a prior invasive malignancy (unless disease-free for at least 3 years).
- Patients may not have had surgical resection of the present cancer.
- Women who are pregnant or breastfeeding will be excluded.
- Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any 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.
- Patients must not have severe lung disease defined by a history of severe chronic obstructive pulmonary disease (COPD) requiring 3 or more hospitalizations over the past year, or history of interstitial pneumonitis.
- Patients must not have any concurrent active malignancy.
- Patients must not have evidence of metastatic disease.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01797471
Start Date
March 1 2013
End Date
November 6 2013
Last Update
December 21 2017
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136