Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 5, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Drug: Hypofractionated Radiation Therapy; Radiation: Radiation Boost
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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).
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 5, 2022. Always confirm current availability with the study team.