Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with non-small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving proton beam radiation therapy together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of proton beam radiation therapy when given together with cisplatin and etoposide and to see how well it works in treating patients with stage III non-small cell lung cancer that can be removed by surgery.
研究概览
详细说明
PRIMARY OBJECTIVES:
I. To assess feasibility. (Phase I) II. To determine dose-limiting toxicity and maximum tolerated dose. (Phase I) III. To determine the pathologic CR rate. (Phase II)
SECONDARY OBJECTIVES:
I. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy. (Phase II) II. To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy. (Phase II) III. To compare the dose distribution to tumor and surrounding normal structures using DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. (Phase II) IV. To determine progression-free survival (Phase II) and late toxicity.
OUTLINE: This is a phase I, dose-escalation study of proton beam radiation therapy followed by a phase II study.
Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity.
Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion
- Histologically confirmed diagnosis of NSCLC
- Stage IIIA or Potentially resectable superior sulcus tumors
- No evidence of distant metastatic disease as documented by MRI of the brain and PET/CT
- Patients must have a Karnofsky Performance Status of >= 60
- Patients must be able to provide informed consent
- WBC >= 4000/mm^3
- Platelets >= 100,000 mm^3
- Creatinine =< 1.2 mg/dl (urinary diversion is permitted to improve renal function)
- Patients must have bilirubin =< 1.5 mg/dl
- Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented
- Negative pregnancy test for women of child-bearing age
Exclusion
- Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) [For pts that will be on definitive treatment study, otherwise delete for umbrella recurrent protocol]
- Pregnant women, women planning to become pregnant and women that are nursing
- Actively being treated on any other research study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm I
Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. |
鉴于IV
其他名称：
鉴于IV
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Deemed Feasible to Receive Intervention
大体时间：90 Days
|
Feasibility will be based on multiple radiation planning and treatment parameters.
Study will be deemed feasible if all patients are deemed feasible.
|
90 Days
|
|
Dose-limiting Toxicity
大体时间：90 Days
|
DLT is defined as post-operative mortality (within 30 days of surgery) or any grade 3 or higher pneumonitis or any other grade 4 or higher toxicity which occurs during chemoradiation or within 90 days following the end of treatment, whichever is longer.
|
90 Days
|
|
Late Toxicity
大体时间：4.5 Years
|
Late toxicity is defined as any grade 3 or higher pneumonitis or any grade 4 or higher toxicity which occurs more than 90 days after surgery or completion of treatment.
|
4.5 Years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pathologic CR Rate
大体时间：90 days
|
Pathologic CR rate is defined as the fraction of patients who undergo surgery and have no evidence of disease based on surgical pathology.
|
90 days
|
合作者和调查者
调查人员
- 首席研究员：Jacob Shabason, MD、Abramson Cancer Center of the University of Pennsylvania
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.