Clinical trial NCT02059967 (phase 1, status: withdrawn)
Conditions: adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, stage iia non-small cell lung cancer, stage iib non-small cell lung cancer, stage iiia non-small cell lung cancer, stage iiib non-small cell lung cancer
ICD codes: D02.20, D02.21, D02.22, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: paclitaxel, carboplatin
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    due to no accrual.
  
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.