NCT06637462招募中不适用
DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Clinical response
研究概览
简要总结
The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more about how people with rectal cancer respond to chemoradiation and chemotherapy treatment and if it is useful for predicting whether a person's cancer get better, gets worse, or stats the same after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •18 years of age or older on day of signing informed consent.
- •Have a histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification.
- •Eligible for and plan to initiate standard-of-care therapy with any of the following regimens:
- •Induction fluoropyrimidine (capecitabine [preferred] or 5-FU) based chemoradiation
- •With plan for consolidative CAPEOX, FOLFOX, or FOLIRINOX
- •Woman with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use an effective contraceptive method. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Reliable contraception should be used from the time of screening and must be continued throughout the duration of treatment as per standard of care.
排除标准
- •Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- •Patients with prior external beam radiation therapy to the pelvis or brachytherapy seed implantation of the prostate.
- •Patients who are pregnant or breastfeeding.
- •Men or women not using effective contraception.
- •Patients with a contraindication to MR imaging.
- •Patients on blood thinners prohibiting endoluminal tumor biopsies.
研究组 & 干预措施
Participants with Rectal Cancer
Experimental
Participants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy.
干预措施: Endoscopy (Diagnostic Test)
结局指标
主要结局
Clinical response
时间窗: Up to 3 years
To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
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