Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

This is an interventional treatment trial for Stage II Non-Small Cell Lung Cancer AJCC v7 Read More

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of non-small cell lung cancer

• Clinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist

  • Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible
  • Patients who refuse surgery are eligible
  • Patients who develop local recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible
  • Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are eligible

• Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

  • History/physical examination within 30 days prior to registration including resting heart rate;
  • Fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration
  • Magnetic resonance imaging (MRI) scan with contrast of the brain (preferred) or CT scan of the brain with contrast within 60 days prior to registration;

  • Forced expiratory volume in one second (FEV1) >= 0.8 liter or >= 35% predicted with or without bronchodilator within 90 days prior to registration;

    • Patients who meet the criterion above without oxygen (O2), but who need acute (started within 10 days prior to registration) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable
• Zubrod performance status 0-1 within 30 days prior to registration
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 obtained within 30 days prior to registration
• Platelets >= 100,000 cells/mm^3 obtained within 30 days prior to registration
• Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable), obtained within 30 days prior to registration

• Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) within 30 days prior to registration

  • It is highly recommended but not required that SGOT or SGPT be =< 1.5 upper limit of normal

• Total bilirubin =< 1.5 within 30 days prior to registration

  • It is highly recommended but not required that total bilirubin be =< 1.5 upper limit of normal
• Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula
• Peripheral neuropathy =< grade 1 at the time of registration

• Patients with non-malignant pleural effusion are eligible

  • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:

    • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative
    • Exudative pleural effusions are excluded, regardless of cytology
    • Effusions that are minimal (i.e, not visible on chest x-ray) that are too small to safely tap are eligible
• Patients must have measurable or evaluable disease
• Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration
• Women of childbearing potential and male participants must practice adequate contraception
• Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

• Prior invasive malignancy unless disease free for a minimum of 3 years; however, skin cancer and in situ carcinomas of the breast, oral cavity, cervix, and other organs and are permissible
• Patients with prior history of either small cell lung cancer or NSCLC regardless of the treatment received, other than patients who have recurrent disease following resection
• Prior systemic chemotherapy for the study cancer, if more than 4 cycles of induction chemotherapy or more than 6 months of targeted therapy; note that prior chemotherapy for a different cancer is allowable
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

• Severe, active co-morbidity, defined as follows:

  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
  • Transmural myocardial infarction within the last 6 months;
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration;
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
• Unintentional weight loss > 10% within 30 days prior to registration
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception