TerminatedPhase 2NCT04398199

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.

Checked against the public recordLast updated Oct 5, 2022 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorWake Forest University Health Sciences
01
Study overview

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
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

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.

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