2025-522955-25-00招募中4 期
Next Generation StaR TREC - Save the rectum by watchful waiting after (chemo)Radiotherapy or Total mesorectal excision for early REctal Cancer?
Vaestra Goetalandsregionen3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Ratio of patients with a non-operative approach at onset that after evaluation by a combination of MRI, clinical and endoscopic examination have a clinical complete response at 1 year.
研究概览
简要总结
The primary objective of this trial is to achieve a sustained clinical complete response rate in patients 1 year after treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The subject has given their written consent to participate in the trial
- •Be 18 years or older
- •Have an adenocarcinoma verified tumour within the rectum below 12 cm from anal verge
- •Have a tumour stage of TX/T1-3b (regardless of tumour size)
- •Have no nodal metastases (NX/N0)
- •Have no distant metastases (MX/M0)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •For female subjects of childbearing potential: Have a negative pregnancy test within 7 days prior to study entry and Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment
- •If non-sterilised male with a partner of childbearing potential, must: Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment
排除标准
- •Give no informed consent
- •Have no residual luminal tumour following endoscopic resection prior to first visit at surgical department
- •Have contraindications to radiotherapy including previous pelvic radiotherapy
- •Have uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry)
- •Have known complete dihydropyrimidine dehydrogenase (DPYD) deficiency
- •Have known Gilbert’s disease (hyperbilirubinemia)
- •Have been taking coumarin-derivative anticoagulants (e.g. warfarin) that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin
- •Are taking metronidazole, phenytoin or sorivudine or its chemically related analogues, such as brivudine, within 4 weeks of trial entry (see Section 8.3.5 for further details)
- •Are Pregnant or lactating woman
- •Have history of severe and unexpected reactions to fluoropyrimidine therapy
- •No biopsy confirmed rectal cancer (adenocarcinoma)
- •Have a recurrent rectal cancer
- •An age below 18
- •Have concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years
- •Have unequivocal evidence of metastatic disease (includes respectable metastases)(Patients with equivocal radiological lesions (e.g. retroperitoneal, liver, lung) that are not classified as M1 are eligible if agreed by MDT)
- •Have an MRI node positive tumour (≥N1, defined by protocol guidelines) (Patients with equivocal radiological findings that are either classified as NX or N0 are eligible)
- •Have MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)
- •Have a threatened mesorectal fascia (≤1 mm on MRI or ERUS)
结局指标
主要结局
Ratio of patients with a non-operative approach at onset that after evaluation by a combination of MRI, clinical and endoscopic examination have a clinical complete response at 1 year.
Ratio of patients with a non-operative approach at onset that after evaluation by a combination of MRI, clinical and endoscopic examination have a clinical complete response at 1 year.
次要结局
- Local recurrence
- Local regrowth
- Survival (overall)
- Metastases
- Organ preservation rate
- Clinical complete response rate
- Morbidity measured with Comprehensive Complications Classification Index (41)
- Total length of hospital stay
- Radical resection (R0) after surgery
- Urinary function
- Sexual function
- Bowel function
- Presence of a stoma
研究者
Eva Angenete
Scientific
Vaestra Goetalandsregionen
研究点 (3)
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