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临床试验 NCT06991465 (Hypo-OPRA) 针对结直肠癌目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA) II期 35
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临床试验NCT06991465 (Hypo-OPRA)旨在研究治疗，主要针对结直肠癌。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2023年8月16日，计划招募35名患者。该研究由Neil Kopek主导，预计于2029年6月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年5月28日。
简要概括
The combination of preoperative pelvic RT - either long-course chemoradiotherapy (LCCRT) or short-course radiotherapy (SCRT)- followed by surgery has been the standard of care in the curative treatment of locally advanced adenocarcinoma of the rectum for decades. Some patients however achieve a complete clinical response (cCR) to their preoperative treatment which opens the possibility of avoiding surgery and consequ...显示更多
详细描述
At McGill, SCRT is used routinely as a pre-operative radiotherapy schedule for locally advanced adenocarcinomas of the rectum. Likewise SCRT followed by chemotherapy is already used routinely at McGill as a pre-operative regimen for locally advanced rectal cancer with high risk features. Compelling registry data from Scandinavia shows that enduring clinical complete responses can be achieved after SCRT. To date, howe...显示更多
官方标题
Organ Preservation in Rectal Adenocarcinoma Using Hypofractionated Pelvic Radiotherapy (Hypo-OPRA): A Phase II Clinical Trial
疾病
结直肠癌出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- Hypo-OPRA
- 2023-9472
NCT编号
实际开始日期
2023-08-16
最近更新发布
2025-05-28
预计完成日期
2029-06-30
计划入组人数
35
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
招募中
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Hypofractionated Pelvic Radiotherapy A single arm consisting of hypofractionated RT dose of 25 Gy in 5 fractions once daily fractions of intensity modulated radiotherapy (IMRT) with a simultaneous integrated boost up to 35 Gy on sites of gross disease (tumour and lymphadenopathy). | 放射治疗 High Dose Hypofractionated Radiotherapy 35 Gy over 5 fractions. FOLFOX regimen Radiosensitizing chemotherapy Capecitabine Radiosensitizing chemotherapy |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Feasibility of Hypo-fractionated Approach in 5 fractions for a dose of 35Gy | Rate of failure to achieve CR or the rate of recurrence after achieving CR | One year |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Histologically confirmed invasive adenocarcinoma of the rectum
- Pelvic MRI defined disease (at least one of the following):
mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4)
- Patients are considered medically fit for oncologic resection
- ECOG performance status 0 or 1
- No evidence of established metastatic disease (CT chest and abdomen)
- Absolute neutrophil count >1.5x109/L; platelets >100x109/L,
- Serum transaminase <3 x ULN;
- Adequate renal function (Cockroft Gault estimation >50 mL/min)
- Bilirubin <1.5 x ULN
- Ability to comply with oral medication
- Willingness and ability to give informed consent and comply with treatment and follow up schedule
- Age 18 or over
- Previous chemotherapy
- Previous radiotherapy to the pelvis (including brachytherapy)
- Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
- T1 or T2 N0 disease without extra-mural venous invasion
- Unequivocal evidence of metastatic disease (includes resectable metastases)
- Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence
- Known dihydropyrimidine dehydrogenase deficiency
- History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix.
- Known Gilberts disease (hyperbilirubinaemia)
- Taking warfarin or phenytoin or sorivudine
- Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
- Pregnant, lactating, or pre-menopausal women not using adequate contraception
- Unfit to receive any study treatment or subsequent surgical resection
Neil Kopek麦吉尔大学研究责任方
Neil Kopek, 申办者-研究者, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
研究中心联系人
联系人: Neil Kopek, M.D., 514-934-4400, [email protected]
联系人: Tarel Hijal, M.D., 514-934-4400, [email protected]
1 位于 1 个国家/地区的研究中心
Quebec
McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada
Neil Kopek, M.D., 联系人, 514-934-4400, [email protected]
Tarek Hijal, M.D., 联系人, 514-934-4400, [email protected]
招募中