NCT07337876招募中2 期
Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Two year TME-free survival
研究概览
简要总结
This study is testing whether radiation delivered with MRI guidance using a so-called MR-linac in distal rectal cancer can result in a high rate of organ preservation. Patients will receive radiotherapy together with standard chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with histologically confirmed diagnosis of rectal cancer localized between dentate line and 12 cm from the anocutaneous line
- •Any MRI staged rectal cancer meeting the following criteria
- •cT1-cT3 and
- •cN0 -cN1 and
- •Inclusion of UICC Stage I tumors only if unsuitable for endoscopic resection or if primary surgery would require permanent colostomy or deep anastomosis with expected poor organ function.
- •Tumor affects less than 70% of the rectal circumference.
- •Maximum longitudinal extension of the tumor less than 8 cm on MRI
- •MR-Staging requirements: High-resolution, thin-sliced (i.e.
- •≤3mm) magnetic resonance imaging (MRI) of the pelvis.
- •Cross-sectional imaging of the abdomen and chest to exclude distant metastases.
- •Aged at least 18 years. No upper age limit.
- •WHO/ECOG Performance Status ≤ 1
- •Adequate hematological, hepatic, renal and metabolic function parameters
- •Informed consent of the patient
排除标准
- •Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
- •Distant metastases
- •Preexisting fecal incontinence for solid stool
- •Prior antineoplastic therapy for rectal cancer
- •Prior radiotherapy of the pelvic region
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- •Other concomitant antineoplastic therapy
- •Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active,uncontrolled infections, active, disseminated coagulation disorder
- •Other primary tumors with an estimated life expectancy of less than three years
- •Contraindications for treatment with 5-Fluorouracil or Capecitabine
- •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).
研究组 & 干预措施
MR guided dose escalated radiotherapy
Experimental
A dose of 65 Gy is delivered to the primary tumor and affected lymph nodes.
干预措施: Dose escalated radiotherapy using a 1.5 T MR-Linac (Radiation)
结局指标
主要结局
Two year TME-free survival
时间窗: Two years from the start of radiotherapy
Patients alive and without TME-surgery
次要结局
- Clincal complete response rate(three months after the end of radiotherapy)
研究者
Dr. Cihan Gani
Prof.
University Hospital Tuebingen
研究点 (1)
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