NCT03961776招募中不适用
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
Institut Paoli-Calmettes2 个研究点 分布在 2 个国家目标入组 39 人开始时间: 2020年6月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Predictive value of Apparent Diffusion Coefficient measured using MRgRT system
研究概览
简要总结
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
详细描述
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient over 18 years old.
- •Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
- •Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
- •Signed consent to participation.
- •For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
- •Affiliation to a social security regimen, or beneficiary of such a regimen.
排除标准
- •Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
- •Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
- •Exclusive radiation therapy.
- •Other associated neo-adjuvant treatment.
- •Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
- •Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance <30 ml / min),
- •Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
- •Participation in a protocol with concurrent treatment.
- •Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
- •Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
- •Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.
结局指标
主要结局
Predictive value of Apparent Diffusion Coefficient measured using MRgRT system
时间窗: At surgery (5 to 10 weeks after completion of chemoradiation)
Pathological complete response using AJCC criteria
次要结局
未报告次要终点
研究者
研究点 (2)
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