Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Wake Forest University Health Sciences
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Updated on 5 August 2020
See if I qualify
cancer
lung cancer
systemic therapy
pet/ct scan
concurrent chemotherapy
mri brain
hypofractionated radiation therapy
non-small cell lung cancer
small cell lung cancer
stage ii non-small cell lung cancer
nonsmall cell lung cancer stage

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.

Description

Primary Objective:

To determine the in-field control of hypofractionated radiotherapy consisting of 70 Gy in 25 fractions without concurrent chemotherapy measured at two years after the first postradiotherapy scan.

Secondary Objective(s):

  • To determine the toxicity profile of thoracic hypofractionated radiotherapy consisting of 70 Gy in 25 fractions as graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • To determine proportion with local, regional, and distant progression at 1 and 2 years after the first post-radiotherapy scan, and compute progression-free and overall survival (progression-free survival and overall survival, respectively).

Details
Condition Nonsmall Cell Lung Cancer, Stage II, Nonsmall Cell Lung Cancer Stage III
Age 18years - 100years
Treatment Hypofractionated Radiation Therapy, Radiation Boost
Clinical Study IdentifierNCT04398199
SponsorWake Forest University Health Sciences
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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 as determined by PET/CT and MRI Brain
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
Participant is not eligible for or has declined surgical resection 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
Endobronchial tumor noted on bronchoscopy
Radiographic invasion of the heart or main, left, or right pulmonary artery or vein, or aorta
Radiographic encasement of the trachea, left, or right mainstem bronchus
Prior systemic therapy or surgery for the study cancer
Participants may not be receiving any other investigational agents
Prior malignancy within the past two years except for non-melanoma skin 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
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the treating physician
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