Phase II Study of Pulsed Low Dose Rate Radiation Therapy for Gastric Cancer Patients With Peritoneal Metastasis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Side effects of pulsed low dose rate radiation therapy
研究概览
简要总结
This phase II trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis.
详细描述
This phase II trial studies the side effects and response of pulsed low dose rate radiation therapy in treating gastric cancer patients with peritoneal metastasis. Radiation therapy uses pulsed low dose rate high energy X rays to kill tumor cells and make less side effects than conventional 3-dimensional conformal radiation therapy. Palliative radiation therapy may help gastric cancer patients with peritoneal metastasis live more comfortably.
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
- •Patients must have histologically-confirmed gastric adenocarcinoma
- •Patients must have metastasis tumor located within peritoneal cavity
- •Tumor within the irradiated field is negatively impacting patient's quality of life or threatening catastrophic complication if left untreated as determined by the treating physician
- •Patient is not a surgical candidate or tumor is not surgically resectable, as documented by surgical oncologist
- •Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, or other therapies
- •Patients must have measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 in the irradiated field
- •Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to radiation simulation, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed
- •Eastern Cooperative Oncology Group (ECOG) performance status determined to be between 0 and 3
- •Absolute neutrophil count (ANC) >=1,000/ul
- •Platelets (PLT) >=75,000/ul
- •Subjects must sign a written informed consent and Health Insurance Probability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures of assessments and must be willing to comply with treatment and follow-up
排除标准
- •Patients who have had chemotherapy or radiotherapy to the reirradiation target within 4 weeks prior to entering the study
- •A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
- •Scleroderma or active connective tissue disease
- •Active inflammatory bowel disease
- •Serious, active infections requiring treatment with intravenous (IV) antibiotics
- •Uncontrolled intercurrent illness including, but not limited to, or psychiatric illness/social situations that would limit compliance with study requirements
结局指标
主要结局
Side effects of pulsed low dose rate radiation therapy
时间窗: Up to 30 days
Number of participants with adverse events and the grade of adverse events. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
次要结局
- Objective response(Up to 30 days)
- Palliative efficacy in terms of quality of life and pain levels(Up to 3 years)
- Duration of response(Up to 3 years)
- Time to progression(Up to 3 years)
研究者
Yang Yang
Principal Investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School