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Phase II

Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

  • Study HIC#:2000025868
  • Last Updated:07/30/2021

The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.

  • Start Date05/28/2020
  • End Date01/31/2030

Trial Purpose and Description

The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 60 NSLCsubjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results.

The outcomes of the metastatic patients will also be reported.

There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.

Eligibility Criteria

Inclusion Criteria:

  • Tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, 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), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on Radiation Therapy Oncology Group (RTOG) and MD Anderson Cancer Center definitions). The principal investigator (PI) will review and prospectively approve any lesions abutting these organs.
  • For primary NSCLC patients, clinically staged as T1, N0, M0 or T2, N0, M0 per American Joint Commission on Cancer (AJCC) 8th edition.
  • Lung metastases ≤ 5 cm of any histology may be considered. Only one tumor may be treated during the treatment course
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • Age > 18
  • Patients must sign a study-specific consent form.

Exclusion Criteria:

  • prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as organ at risk (OAR) structures in the receiving the following doses ( in <3 Gray (Gy) per fraction):
  • Spinal cord previously irradiated to > 40 Gy
  • Brachial plexus previously irradiated to > 50 Gy
  • Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
  • Brainstem previously irradiated to > 50 Gy
  • Lung previously irradiated with prior V20Gy > 35%
  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
  • No plan for the patient to receive other concomitant antineoplastic treatment (including chemotherapy, biological therapy, vaccine therapy, and surgery)
  • May not be pregnant or lactating
  • No other medical condition or reason that, in the opinion of the investigator, would preclude study participation