Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT02059967
Eligibility Criteria:
Inclusion Criteria:
* Histologically-proven (by biopsy or cytology), unresectable or inoperable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma not otherwise specified.
* The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung 2.gif for staging.
* All detectable tumor must be encompassed by radiation therapy fields.
* 18-fluorodeoxyglucose PET is required for staging and treatment planning.
* Atelectasis, if present, must involve less than a complete lung.
* Laboratory values:
* Neutrophils \>1500/µL
* Platelets \>100,000/µL
* Bilirubin \< 1.5 mg/dL
* Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase \[SGOT\]) \< 2x upper limit normal
* Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase \[SGPT\]) \< 2x upper limit normal
* Serum creatinine \< 2.0 mg/dL
* Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days must be ≥ 59 mL/min
* Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec
* Plan of curative radiotherapy with or without concurrent chemotherapy.
* Karnofsky Performance Scale score of ≥ 70%.
* Age ≥ 18 years old.
* Measurable disease on the planning CT.
* Patient must have a completed IMRT plan to 66 Gy in 2 Gy fractions with ≥ 95% of the PTV covered by the prescription dose, and the attending physician must have reviewed and approved the DVHs as follows:
* total lung V20 Gy ≤ 30%
* mean esophageal dose ≤ 34 Gy
* esophageal planning organs-at-risk volume (PRV) V60 Gy ≤ 30%
* heart V40 Gy ≤ 50%
* maximum brachial plexus dose ≤ 66 Gy
* maximum spinal cord PRV dose ≤ 50 Gy
* maximum aorta dose ≤ 66 Gy
* maximum main bronchus dose ≤ 66 Gy
* maximum dose ≥ 66 Gy allowed in only one lobar bronchus.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
* Prior radiation therapy to the thorax.
* Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past 5 years.
* Clinically significant pleural effusions, pericardial effusions, or superior vena cava syndrome.
* Oxygen supplementation required during therapy.
* Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus.
* Tumors that affect more than one lobar bronchus, except the second involved bronchus in the right middle lobe bronchus.
* Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm.
* Myocardial infarction within the last 6 months, symptomatic heart disease, uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled bronchospasms.
* History of a prior malignancy from which the patient has not been disease free for a minimum of 2 years, other than adequately treated basal/squamous skin cancer or in situ cervix cancer or other in situ malignancy.
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02059967
Study Brief:
Protocol Section:
NCT02059967