Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial) (IDEAL)
2021年2月4日 更新者：Duke University
The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
研究概览
研究类型
介入性
注册 (实际的)
12
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
North Carolina
-
Durham、North Carolina、美国、27710
- Radiation Oncology, DUMC
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior radiation to the abdomen or pelvis
- A history of Scleroderma or Inflammatory bowel disease
- Contraindication to chemotherapy or radiation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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：Boost Radiation: Dose Level 1
2.4 Gy X 25 fractions = 60 Gy
|
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
|
实验性的：Boost Radiation: Dose level 2
2.6 Gy X 25 fractions = 65 Gy
|
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
|
实验性的：Boost Radiation: Dose level 3
2.8 Gy x 25 fractions = 70 Gy
|
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
|
实验性的：Experimental: Boost Radiation Dose Level 0
If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below. Dose level 0: 2.2 Gy X 25 fractions = 55 Gy |
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3).
This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
|
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 |
|---|---|---|
|
Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).
大体时间：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.
|
During RT to 6 weeks post RT
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)
大体时间：3 years following treatment
|
Local-regional control is defined as local control without any nodal recurrence.
|
3 years following treatment
|
|
Time to Distant Recurrence (TTDR)
大体时间：3 years after treatment
|
3 years after treatment
|
|
|
Disease Free Survival (DFS)
大体时间：3 years after treatment
|
3 years after treatment
|
|
|
Overall Survival (OS)
大体时间：3 years after treatment
|
3 years after treatment
|
|
|
Number of Participants With Acute Dose Limiting Toxicities (DLT)
大体时间：6 weeks following treatment
|
Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT).
Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.
|
6 weeks following treatment
|
|
Number of Participants With Late Dose Limiting Toxicities (DLT)
大体时间：3 years following treatment
|
Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.
|
3 years following treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Junzo Chino, MD、Duke Cancer Center/Radiation Oncology
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年6月4日
初级完成 (实际的)
2018年11月16日
研究完成 (实际的)
2019年11月16日
研究注册日期
首次提交
2012年6月21日
首先提交符合 QC 标准的
2012年6月22日
首次发布 (估计)
2012年6月25日
研究记录更新
最后更新发布 (实际的)
2021年2月8日
上次提交的符合 QC 标准的更新
2021年2月4日
最后验证
2021年2月1日
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.