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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Presence or Absence of In-Field Progression
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Hypofractionated Radiation Therapy
Hypofractionated radiation therapy will be delivered to all participants. The radiation will be planned in a special way to give the biggest parts of the tumors that are the most difficult to control a little more radiation every day than the lower risk areas.
干预措施: Hypofractionated Radiation Therapy (Drug)
Hypofractionated Radiation Therapy
Hypofractionated radiation therapy will be delivered to all participants. The radiation will be planned in a special way to give the biggest parts of the tumors that are the most difficult to control a little more radiation every day than the lower risk areas.
干预措施: Radiation Boost (Radiation)
结局指标
主要结局
Presence or Absence of In-Field Progression
时间窗: At 2 years
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.
次要结局
- Proportion of Participants Experiencing Grade 2 or Higher Toxicities(25 months)
- Proportion of Participants That Experienced Local Progression(At 1 and 2 years after first post-radiotherapy scan)
- Progression-Free Survival(Up to 2 years)
- Overall Survival(Up to 2 years)