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

Nonsmall Cell Lung Cancer Stage III Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04398199
• Other study ID #: IRB00065905
• Secondary ID: WFBCCC 62220
• Status: Terminated
• Phase: Phase 2
• Start date: October 16, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: September 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer Stage III
• Nonsmall Cell Lung Cancer, Stage II

Intervention

Drug:
• Hypofractionated Radiation Therapy
The prescribed dose will be 70 Gy in 25 fractions. Participants will radiation therapy once a day for 25 days, Monday through Friday (around 5 weeks).

Radiation:
• Radiation Boost
Undergo simultaneous integrated boost (SIB) to treat both planned target volumes with daily image guidance. This approach allows daily confirmation of target localization and simultaneous delivery of lower dose per fraction to low risk areas while maintaining a high dose per fraction to the highest risk areas.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or Absence of In-Field Progression	In-field progression is defined as growth of the targeted lesions beyond the treated volume. The treated volume will be defined as the 28.75 Gy isodose line (50% of 57.5 Gy). Pathologic confirmation of tumor progression is preferred, but can be determined radiographically by Multidisciplinary Thoracic Oncology Program consensus if biopsy of the lesion in question is not feasible or safe. Investigators will compare the proportion of the sample with any in-field progression at 2 years to the historical control proportion of 0.5, using a one-sample z-test.	At 2 years
Secondary	Proportion of Participants Experiencing Grade 2 or Higher Toxicities	Toxicities will be evaluated per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 constructed with a 95% confidence interval.	25 months
Secondary	Proportion of Participants That Experienced Local Progression	Participants who have experienced local progression by 13 months (1 year following first post-radiotherapy scan) and by 25 months (2 years following first post-radiotherapy scan), and will also compute the same two proportions considering regional progression, distant progression, and any (of the 3 categories) progression. A 95% confidence intervals around these proportions will be constructed. Participants for whom investigators are unable to determine progression status at 1 and 2 years (e.g., because they do not return for the necessary scans, or because they die without evidence of progression) will be left out of these analyses.	At 1 and 2 years after first post-radiotherapy scan
Secondary	Progression-Free Survival	Progression-free survival will be evaluated by considering the time from registration to progression of disease or death; those who do not experience either outcome will be censored at date of last visit. Using the Kaplan-Meier lifetable method, and will estimate median survival and corresponding 95% confidence intervals; investigators will also explore simple Cox proportional hazards models of this survival outcomes, to examine the predictive influence of variables such as age, gender, ECOG performance status, stage at diagnosis, planning target volume (PTV) 7000 volume, and planning target volume (PTV) 5750 volume.	Up to 2 years
Secondary	Overall Survival	Overall survival will be evaluated by considering the time from registration to death from any cause; those who do not die will be censored at date of last visit. Using the Kaplan-Meier lifetable method, and will estimate median survival and corresponding 95% confidence intervals; investigators will also explore simple Cox proportional hazards models of this survival outcomes, to examine the predictive influence of variables such as age, gender, ECOG performance status, stage at diagnosis, planning target volume (PTV) 7000 volume, and planning target volume (PTV) 5750 volume.	Up to 2 years