A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
This research study is looking at an alternative way of delivering radiation therapy with protons. Protons are tiny particles with a positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Information from other research studies suggests that proton radiation may help to reduce unwanted side effects from radiation and allow an increase in radiation dose that increase the odds of tumor killing.
The purpose of this study is to determine the safest dose of proton radiation therapy to give in combination with standard chemotherapy in participants with Non-Small Cell Lung Cancer (NSCLC).
详细描述
Proton radiation will be delivered daily Monday through Friday for 5 weeks. Study therapy will be give as an outpatient at the Francis H. Burr Proton Center at Massachusetts General Hospital.
During the weeks that subjects receive radiation, they will also receive 2 cycles of chemotherapy. Each cycle will last 28 days.
Cisplatin will be give as an IV infusion over 30-60 minutes or 1-2 hours on Days 1 and 8 of Cycles 1 and 2.
Etoposide will be given as an IV infusion over 60 minutes on Days 1, 2, 3, 4, 5 of Cycles 1 and 2.
After radiation and 2 cycles of chemotherapy are completed, subjects may have surgery to remove their tumor.
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
- •Histologically confirmed non-small cell lung cancer with a clinical stage of IIIA
- •Candidate for chemoradiation and surgical resection
- •Measurable disease
- •Life expectancy > 6 months
- •Normal organ and marrow function
排除标准
- •Pregnant or breast-feeding
- •Prior therapy for lung cancer with chemotherapy
- •Prior chest radiation
- •Compromised pulmonary function
- •Severe neurovascular disease
- •History of high cardiac risk including unstable angina
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, clinically significant or serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •History of a different malignancy unless disease-free for at least 3 years and at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, non muscle-invasive bladder cancer, basal cell or squamous cell carcinoma of the skin
- •Subjects with HIV
研究组 & 干预措施
Radiation, Chemotherapy and Surgery
Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.
干预措施: Proton Beam Radiation (Radiation)
Radiation, Chemotherapy and Surgery
Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.
干预措施: Cisplatin (Drug)
Radiation, Chemotherapy and Surgery
Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.
干预措施: Etoposide (Drug)
结局指标
主要结局
MTD
时间窗: 1.5 years
To establish the MTD of a proton beam-based regimen consisting of 25 fractions, together with concurrent standard cisplatin and etoposide chemotherapy followed by surgery +/- adjuvant chemotherapy for Stage III NSCLC, and to describe post-treatment surgical complications and treatment toxicity using CTCAE v4.0
次要结局
- Downstaging and Response(1.5 years)
- Biomarkers(1.5 years)
- Tumor Control and Survival Rates(5 years)
研究者
Henning Willers, M.D.
Principal Investigator
Massachusetts General Hospital