- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01797471
Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer
A Phase 1 Study for Evaluating the Safety of Lattice Extreme Ablative Dose (LEAD) Radiotherapy Followed by Standard-Dose Chemoradiation for Patients With Bulky Stage III Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 involved sites of disease and a platinum doublet.
The investigational radiation treatment, a single fraction of LEAD radiation, is to be followed by conventionally fractionated radiation delivered concurrently with a standard chemotherapy regimen for stage III non-small cell lung cancer. The following day, patients will begin concurrent chemotherapy and radiation. Chemotherapy will be delivered under the management of the treating medical oncologist. Chemotherapy must be a platinum doublet. Carboplatin and cisplatin are both considered acceptable platinum agents. The use of cisplatin over carboplatin is strongly encouraged, unless the patient has a contraindication to cisplatin. The second agent will be at the discretion of the treating medical oncologist; in the current era, chemotherapy agents are tailored to each patient based on tumor histology, as well as comorbidities that dictate the tolerance of certain chemotherapeutic agents. Chemotherapy will be delivered concurrently throughout radiation therapy, beginning on day 2 of the treatment protocol and on the same day as the start of standard-dose radiation. Weekly regimens or regimens delivered every 3 weeks are acceptable. Additional cycles of consolidation chemotherapy are encouraged and will be given at the discretion of the treating medical oncologist.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LEAD RT
|
A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Treatment-related Toxicity in Study Participants
Time Frame: Up to 12 months
|
Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants.
Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Study Participants Achieving Complete or Partial Response Via CT RECIST Response Criteria
Time Frame: Assessed up to 2 years
|
Number of subjects achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria on CT Scan:
|
Assessed up to 2 years
|
Rate of Study Participants Achieving Complete or Partial Response Via PET Response Criteria
Time Frame: Assessed up to 2 years
|
Rate of subjects achieving complete response (CR) or partial response (PR) as detected by positron emission tomography (PET) Scan:
|
Assessed up to 2 years
|
Rate of Loco-regional Failure in Study Participants
Time Frame: Assessed up to 2 years
|
Rate of loco-regional failure in study participants.
Loco-regional failure is defined as any evidence of disease progression within the primary primary tumor or regional lymph nodes, detected by any method.
|
Assessed up to 2 years
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Progression-Free Survival (PFS)
Time Frame: Assessed up to 2 years
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Rate of progression-free survival (PFS).
PFS is defined as the length of time from date of treatment initiation until date of documented disease progression or death from any cause, with censoring of patients who are lost to follow-up.
|
Assessed up to 2 years
|
Overall Survival (OS)
Time Frame: Assessed up to 2 years
|
Rate of overall survival (OS) in study participants.
Overall survival is defined as the length of time from the date of treatment initiation until the date of death from any cause.
|
Assessed up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean L Wright, MD, University of Miami Sylvester Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20100446
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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