Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Pneumonia; Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Recurrence
Intervention: Photon Therapy; Proton Therapy; Paclitaxel; Carboplatin
Intervention description: Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete.; Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks.
Group 3: 66 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks.
Each daily treatment should take about 20-30 minutes to complete.; 50 mg/m2 by vein 1 time each week for 7 weeks.; AUC 2 by vein 1 time each week for 7 weeks.
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Locally-advanced non-small-cell lung carcinoma; NSCLC; Lung Cancer; Image-Guided Adaptive Conformal Photon; Proton Therapy; Chemotherapy; Treatment Related Pneumonitis

Summary:

      The goal of this clinical research study is to learn if, compared with regular x-ray
      radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis
      (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in
      patients with lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologically proven, unresected, locoregionally advanced NSCLC without evidence of
             hematogenous metastases (stage II-IIIB disease according to the 7th edition of the
             AJCC Staging Manual) with exception as defined by inclusion #2).

          2. Patients with solitary brain metastasis without sign of progression in the brain at
             the time of registration will be eligible for this trial if there is clinical
             indication for concurrent chemoradiation to the primary disease in the lung.

          3. Suitability for concurrent chemoradiation therapy per treating radiation oncologists
             or treating medical oncologist's: A) Karnofsky performance score of >/= 70, or ECOG
             0-1 B) Unintentional weight loss </= 10% during the 3 months before study entry.

          4. Receipt of induction chemotherapy followed by referral for concurrent chemoradiation
             is allowed for this protocol.

          5. Measurable disease on chest x-ray, contrast-enhanced CT, or PET scan.

          6. Locoregional recurrence after surgical resection, if suitable for definitive
             concurrent chemoradiation is allowed for this protocol.

          7. Forced expiratory volume in the first second (FEV1) >/= 1 liters.

          8. Fluorodeoxyglucose (FDG) -PET scan within 3 months before registration. The
             pretreatment (diagnostic) PET/CT should, whenever possible, be performed together with
             the 4-D CT simulation. PET images acquired either at the time of simulation or
             acquired separately should be registered with the planning CT to assist in tumor
             delineation.

          9. Standard pretreatment evaluations (as decided by treating radiation oncologist,
             medical oncologist, surgeons or pulmonologist), to include MRI or CT scan of the
             brain, contrast CT scan of the thorax and upper abdomen, Whole-body PET/CT, pulmonary
             function tests, lung and cardiac single proton emission computed tomography (SPECT),
             liver function tests (LFT), blood chemistry, renal function tests, and complete blood
             count.

         10. Age >/= 18 years but </= 85 years.

         11. A signed specific informed consent form before study entry.

        Exclusion Criteria:

          1. Small cell histology.

          2. Prior thoracic radiotherapy to regions that would result in overlap of radiation
             therapy fields.

          3. Pregnancy (female patients of childbearing potential must practice appropriate
             contraception).

          4. Enrollment in a clinical trial that specifically excludes IGAPT treatment.

          5. Body weight exceeds the weight limit of the treatment couch.

          6. Oxygen dependent due to preexistent lung disease (COPD, emphysema, lung fibrosis).