Clinical trial NCT04398199: Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients
Official title: A Single Arm Phase II Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients Who Decline or Are Ineligible for Surgery or Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonsmall Cell Lung Cancer, Stage II
Nonsmall Cell Lung Cancer Stage III
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-05-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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 post- radiotherapy 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).

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.

Primary outcomes:
measure: Presence or Absence of In-Field Progression
timeFrame: At 2 years
Secondary outcomes:
measure: Proportion of Participants Experiencing Grade 2 or Higher Toxicities
timeFrame: 25 months
measure: Proportion of Participants That Experienced Local Progression
timeFrame: At 1 and 2 years after first post-radiotherapy scan
measure: Progression-Free Survival
timeFrame: Up to 2 years
measure: Overall Survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Farris, MD
role: PRINCIPAL_INVESTIGATOR
References: