Phase 1 Trial of Ablative Stereotactic MR-Guided Adaptive Reirradiation for Abdominal and Pelvic Tumors

Baptist Health South Florida1 个研究点分布在 1 个国家目标入组 10 人2024年6月5日

适应症Abdominal Cancer Pelvic Cancer

干预措施Reirradiation

概览

阶段: 不适用
干预措施: Reirradiation
疾病 / 适应症: Abdominal Cancer
发起方: Baptist Health South Florida
入组人数: 10
试验地点: 1
主要终点: Grade 5 toxicity
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This research study will enroll people who have cancer in their abdomen or pelvis that was treated previously with radiation therapy. The purpose of this research study is to test the safety and possible harms of treating tumors in these regions with another round of radiation therapy, called reirradiation or "reRT." The researchers want to find out what effects (good and bad) reRT has in people with cancer in the abdomen and pelvis.

注册库

clinicaltrials.gov

开始日期

2024年6月5日

结束日期

2027年6月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Baptist Health South Florida

责任方

Sponsor

入排标准

入选标准

•A primary or metastatic lesion in the abdomen or pelvis for which reirradiation will be delivered. There is no maximum lesion size.
•Single course of prior radiation therapy with prescribed equivalent dose in 2 Gy fractions (EDQ210) of at least 40 Gy.
•50% isodose line of the prior radiation therapy course is expected to overlap at minimum the 50% isodose line of the radiation therapy delivered in this study.
•At least 6 months from completion of prior radiation therapy to initiation of study therapy.
•Eastern Cooperative Oncology Group (ECOG) performance status 0-
•Life expectancy at least 6 months.
•Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it is the participant's preferred method. Should a participant become pregnant or suspect pregnancy while participating in this study, the treating physician must be informed immediately.
•Concurrent hormonal therapy or immunotherapy such as immune checkpoint inhibitor is allowed

排除标准

•Contraindication to having an MRI scan.
•Lesion that would receive study therapy arises from or invades a gastrointestinal (GI) luminal organ (a lesion abutting but not invading a GI luminal organ is permitted)
•Lesion that would receive study therapy is not located in the abdomen or pelvis.
•\> 1 course of overlapping radiation therapy delivered to the abdomen or pelvis.
•\< 70% of the gross tumor volume (GTV) receives at least the 95% of the prescribed dose on the original plan using the simulation day anatomy.
•More than 1 lesion in the abdomen or pelvis that requires reirradiation.
•History of inflammatory bowel disease.
•Unable to acquire DICOM radiation therapy treatment plan from the prior radiation therapy.
•Unresolved grade 2+ toxicity (Common Terminology Criteria for Adverse Events version 5.0) from previous anti-cancer therapy.
•Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of participant safety or study results.

研究组 & 干预措施

Ablative Reirradiation

干预措施: Reirradiation

结局指标

主要结局

Grade 5 toxicity

时间窗: 1 year

Number of participants who experience Grade 5 toxicity (graded per CTCAE) possibly, probably, or definitely related to reRT.

Grade 3 or higher acute toxicity

时间窗: 1 year

Number of participants who experience Grade 3 or higher acute toxicity \[graded per Common Terminology Criteria for Adverse Events (CTCAE)\] possibly, probably, or definitely related to reRT.