NCT04398199

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Nonsmall Cell Lung Cancer, Stage II
• Nonsmall Cell Lung Cancer Stage III

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-16
• Primary completion: 2020-11-20
• Completion: 2020-11-20
• First posted: 2020-05-21
• Last updated: 2022-10-05
• Results posted: 2022-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study