ULtra sensiTive ctDNA-Informed Management eArly-stage recTal cancEr (ULTIMATE)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)
研究概览
简要总结
This is a phase 2 pragmatic study to examine the utility of ctDNA-informed treatment management for participants with early-stage rectal cancer using the Signatera Genome assay. The primary aims are to 1) assess pathologic complete response (path CR) in the ctDNA informed management arm; 2) assess pathologic complete response (path CR) in the post total neoadjuvant therapy (TNT) standard of care (SOC) surgery arm; and 3) assess disease free survival (DFS) in the ctDNA informed management arm.
详细描述
Two cohorts of participants will be enrolled: Cohort A (participants appropriate for receiving TNT) and Cohort B (TNT already performed at UC Davis Health or externally). At Time A after TNT is completed and based on ctDNA assay results, the clinical decision will be made to put participants into one of two arms: the ctDNA informed management arm (Watchful Waiting [WW] surveillance) or the post TNT SOC surgery arm; participants will be monitored for ctDNA positivity for up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Tumor tissue histologically confirming rectal adenocarcinoma that is available for Natera ctDNA assay.
- •Cohort A only: Patients appropriate for receiving TNT including chemotherapy and chemoradiation.
- •Cohort B only: TNT must have included at least 4 cycles of CAPEOX or 6 cycles of FOLFOX and at least 45 Gy in 25 fractions to the pelvis during chemoradiation.
- •Patients ≥18 years of age at time of consent.
- •Ability to understand and willingness to sign the informed consent form (ICF).
- •Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements.
排除标准
- •Prior treatment for rectal cancer, except for cohort B.
- •Evidence of distant metastatic disease on staging imaging (CT chest with abdominopelvic imaging by CT or MRI) within 8 weeks of enrollment.
- •Patients on hemodialysis.
- •Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
研究组 & 干预措施
Post TNT SOC surgery arm
干预措施: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT) (Drug)
ctDNA informed management arm (Watch and Wait surveillance)
干预措施: Signatera Genome ultra-sensitive ctDNA blood test + total neoadjuvant therapy (TNT) (Drug)
结局指标
主要结局
Pathologic complete response (pathCR) rate (ctDNA Informed Management Arm)
时间窗: Up to 2 years after TNT
Percent of participants with local regrowth within 2 years of total neoadjuvant therapy (TNT)
Pathologic complete response (pathCR) rate (Post TNT SOC Surgery Arm)
时间窗: Up to 2 years after TNT
Percent of participants with local regrowth within 2 years of TNT
Disease-free survival (DFS) rate (ctDNA Informed Management Arm)
时间窗: Up to 2 years after TNT
Median interval from first date of TNT to the first occurrence of locoregional failure, distant recurrence, a new invasive colorectal primary cancer.
次要结局
- Frequency of local regrowth (ctDNA Informed Management Arm)(Up to 2 years after TNT)