Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed malignancy of the gynecologic tract
- •Involved pelvic or para-aortic lymph nodes
- •Treatment plan to include delivery of concurrent chemoradiotherapy.
- •Good performance status
- •Negative pregnancy test in women of child-bearing potential
- •Signed study-specific informed consent
- •Lab results within study specific limits
排除标准
- •Prior radiation to the abdomen or pelvis
- •A history of Scleroderma or Inflammatory bowel disease
- •Contraindication to chemotherapy or radiation
结局指标
主要结局
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
时间窗: During RT to 6 weeks post RT
Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.
次要结局
- Number of Participants With Acute Dose Limiting Toxicities (DLT)(6 weeks following treatment)
- Disease Free Survival (DFS)(3 years after treatment)
- Overall Survival (OS)(3 years after treatment)
- Number of Participants With Late Dose Limiting Toxicities (DLT)(3 years following treatment)
- Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)(3 years following treatment)
- Time to Distant Recurrence (TTDR)(3 years after treatment)