Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients
Condition: Nonsmall Cell Lung Cancer, Stage II; Nonsmall Cell Lung Cancer Stage III
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Hypofractionated Radiation Therapy; Radiation Boost
Intervention description: The prescribed dose will be 70 Gy in 25 fractions. Participants will radiation therapy once a day for 25 days, Monday through Friday (around 5 weeks).; Undergo simultaneous integrated boost (SIB) to treat both planned target volumes with daily image guidance. This approach allows daily confirmation of target localization and simultaneous delivery of lower dose per fraction to low risk areas while maintaining a high dose per fraction to the highest risk areas.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out what effects (good or bad) may come from a
      new way of doing radiation therapy for lung cancer. This study is for patients who are not
      able to get surgery or chemotherapy with their radiation. The way of doing radiation therapy
      in this trial is called hypofractionated radiation therapy which is a standard approach, but
      this study allows the actual tumor to get an extra radiation dose while still protecting the
      organs that are near the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of non-small cell lung cancer by either biopsy or cytology

          -  American Joint Committee on Cancer (AJCC) 8th Edition Stage II-III or ultracentral
             Stage IB disease as determined by PET/CT and MRI Brain

          -  Ultracentral disease will be defined as edge of gross visible tumor within 1.0 cm of
             the proximal bronchial tree.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3

          -  Participant is not eligible for or has declined surgical resection or stereotactic
             body radiotherapy as determined by the treating physician

          -  Participant is not eligible for or has declined concurrent chemotherapy as determined
             by the treating physician

          -  While investigators expect it to be an uncommon event, sequential use of systemic
             therapy after completion of radiation therapy is permissible if the participant's
             status improves such that they become eligible for such therapies, per the discretion
             of a multidisciplinary tumor board.

          -  Negative serum or urine pregnancy test within 2 weeks of the date of enrollment for
             women of child-bearing potential.

          -  Ability to understand and the willingness to sign an IRB-approved informed consent
             document (either directly or via a legally authorized representative).

        Exclusion Criteria:

          -  History of previous thoracic radiotherapy with the exception of prior radiotherapy for
             breast cancer without overlap of the fields with the cancer to be treated.

          -  Prior systemic therapy or surgery for the study cancer.

          -  Prior malignancy within the past two years except for non-melanoma skin cancer,
             prostate cancer, or any in-situ malignancy.

          -  Receipt of anti-angiogenic therapy, such as bevacizumab, within 6 months of
             enrollment.

          -  Pregnant women are excluded from this study because radiation therapy has known
             potential for teratogenic or abortifacient effects.