EUCTR2015-000689-79-NL进行中（未招募）不适用
Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers. - TESAR
Vrije Universiteit Medical Center0 个研究点开始时间: 2015年7月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient has had a margin free (at least 1 mm) endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer (below 10 cm).
- •2. Only lesions for which TME surgery is indicated can be included (If a partial mesorectal excision (PME) is indicated the patient should be excluded).
- •3.Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm or pT1, maximum size 3 cm, with at least poor differentiation and/or lymphatic and/or venous invasion
- •4.Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size 3 cm, well differentiated and without lymphatic or venous invasion.
- •5.Complete colonoscopy, without synchronous colorectal cancer
- •6.cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features .
- •7.Adequate distant staging (CT-thorax abdomen) without signs of distant metastasis (cM0)
- •8.Male or female, Age > 18 years.
- •9.Life expectancy of at least 12 months.
- •10.Medically fit (WHO 0-2) to undergo radical surgery and/or radiation
- •11.The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
- •12.Written (signed and dated) informed consent and be capable of co-operating with protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •1.Incomplete or inconclusive resection margin (less than 1mm clearance from the local excision margin or specimens with uncertain deep margin).
- •2.T1 tumour < 3 cm, well differentiated, without venous or lymphatic invasion.
- •3.T1 tumour >5 cm and T2 tumour > 3 cm
- •4. Presence of metastatic disease or recurrent rectal tumour.
- •5.Previous pelvic radiation
- •6.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
- •7.Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
- •8. Pregnancy, breast-feeding or fertile women without active birth control
- •9.Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (<6 months prior to randomization), myocardial infarction (<6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
- •10. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- •11.History of severe and unexpected reactions to fluoropyrimidine therapy
- •12.Hypersensitivity to capecitabine.
- •13. Patients with severe leukopenia, neutropenia, or thrombocytopenia.
- •14.Patients with severe hepatic impairment. 15.Patients with severe renal impairment (creatinine clearance below 30 ml/min).
- •16. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
研究者
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