Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer

Stopped early · Not applicable

Conditions studied: Non-Small Cell Lung Cancer, NSCLC

In brief

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 fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase I clinical trial. The investigators hypothesize that the addition of a one-time single fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity above that expected with standard-dose concurrent chemotherapy and radiation alone.

Key facts

Study ID

NCT01797471

Run by

University of Miami

People needed

1

Starts

2013-03-01

Expected to finish

2013-11-06

Last updated by the study team

2017-12-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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