Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT)
Condition: Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: SBRT (stereotactic body radiotherapy); SBPT (stereotactic body proton therapy)
Intervention description: 50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.; 50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small-cell lung cancer; NSCLC; Centrally-located; Recurrent; Squamous cell carcinoma; Adenocarcinoma; Large cell carcinoma; Bronchioloalveolar cell carcinoma; Non-small cell carcinoma not otherwise specified; Stereotactic Body Radiotherapy; SBRT; Stereotactic Body Proton Therapy; SBPT

Summary:

      The goal of this clinical research study is to compare 2 types of radiotherapy, stereotactic
      body photon radiotherapy (SBRT) and stereotactic body proton radiotherapy (SBPT). Researchers
      would like to compare the side effects, quality of life, and cancer control.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological confirmation (by biopsy or cytology) or clinically diagnosed primary
             non-small cell lung cancer (NSCLC). The following primary cancer types are eligible:
             squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell
             carcinoma, or non-small cell carcinoma not otherwise specified

          2. Centrally located, defined as located within 2 cm of the central bronchial tree
             (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus
             intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe
             bronchi), major vessels (aorta, pulmonary artery trunk, left/right pulmonary
             artery/vein main branches, superior/inferior vena cava, brachiocephalic artery trunk
             or left/right brachiocephalic vein, left/right subclavian artery/vein), esophagus,
             heart, tracheal, pericardium, mediastinal pleural and brachial plexus, chest wall and
             vertebral body, but no direct invasion, Stage I (T1-T2a <= 5 cm without main bronchus
             involvement), selective stage II ( selective T3 with involvement of mediastinal
             pleura, parietal pericardium,) based upon the following minimum diagnostic workup:

          3. continued from criteria #2) History/physical examination including weight and
             assessment of Zubrod performance status within 2 months prior to registration;
             Evaluation by an experienced thoracic cancer clinician within 2 months prior to
             registration; computed tomography (CT) scan with intravenous contrast (unless
             medically contraindicated) of the entirety of both lungs and the mediastinum, most
             part of liver, and adrenal glands acquired within 2 months prior to registration must
             be available. The primary tumor dimension will be measured on the CT in lung window.
             If PET/CT is performed within 2 month prior to registration, CT of chest is
             recommended but nor required. Whole body fluorodeoxyglucose positron emission
             tomography (FDG-PET) within 3 months prior to registration with adequate visualization
             of the primary tumor and draining lymph node basins in the hilar and mediastinal
             regions and adrenal glands; Pulmonary function tests (PFTs):

          4. continued from inclusion #3) Routine spirometry, lung volumes, diffusion capacity
             (within 3 months prior to registration). Patients with hilar or mediastinal lymph
             nodes </= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered
             N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET
             (including suspicious but non-diagnostic uptake) may still be eligible if directed
             tissue biopsy of all abnormally identified areas are negative for cancer. The primary
             tumor should be considered medically inoperable by an experienced thoracic cancer
             clinician for a standard lobectomy and mediastinal lymph node dissection/sampling
             procedure or patient refuses surgery. The patient may have underlying physiological
             medical problems that would prohibit a surgery due to a low probability of tolerating
             general anesthesia, the operation, the postoperative recovery period, or the removal
             of adjacent functioning lung.

          5. continued from inclusion #4) These types of patients with severe underlying health
             problems are deemed "medically inoperable." Standard justification for deeming a
             patient medically inoperable based on pulmonary function for surgical resection of
             NSCLC may include any of the following: Baseline forced expiratory volume in 1 second
             (FEV1) < 50% predicted, postoperative FEV1 < 30% predicted, severely reduced diffusion
             capacity, baseline hypoxemia and/or hypercapnia, exercise oxygen consumption < 50%
             predicted, severe pulmonary hypertension, diabetes mellitus with severe end organ
             damage, severe cerebral, cardiac, or peripheral vascular disease, or severe chronic
             heart disease. If the patient has medically resectable/operable disease but declines
             surgery after consulting with a thoracic surgeon, he/she will be considered eligible.

          6. History of NSCLC treated with surgery and/or radiotherapy previously and disease has
             been cured or clinically no disease progression for more than 6 months, now isolated
             recurrent disease in lung parenchyma and without involvement of main bronchus, chest
             wall, hilar/mediastinal lymph nodes and critical mediastinal structures. Biopsy of
             recurrent disease is recommended.

          7. Zubrod Performance Status 0-2;

          8. Age >/= 18

          9. Women of childbearing potential and male participants must agree to use a medically
             effective means of birth control, such as condom/diaphragm and spermicidal foam,
             intrauterine device (IUD), or prescription birth control pills, throughout their
             participation in the treatment phase of the study.

         10. The patient must provide study specific informed consent prior to study entry.

        Exclusion Criteria:

          1. Direct evidence of hilar or mediastinal lymph nodes or distant metastases after
             appropriate staging studies.

          2. Patients with active pulmonary or pericardial infection.

          3. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
             or fetus.

          4. Patient pulmonary function showed that pre-bronchial dilator FEV1 <25% or DLCO<25%.

          5. Patient currently requiring supplemental oxygen for his/her daily life.

          6. Patient is pacemaker dependent.

          7. Patients </= 18 years of age.