Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC

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.