NL-OMON50184招募中3 期
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 Trial
Amsterdam UMC, locatie VUmc0 个研究点目标入组 302 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 302
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM,
- •EMR/ESD/endoscopic intramuscular dissection or polypectomy) of an early rectal
- •cancer without carcinoma in the resection plane.
- •2. Patients without carcinoma in the resection plane or in case of unreliable
- •resection planes (EMR/ESD) no macroscopic residual tumour confirmed by
- •endoscopy are eligible for randomisation.
- •3. Only lesions for which TME surgery is indicated can be included (If a
- •partial mesorectal excision (PME) is indicated the patient should be excluded).
- •4. Pathological confirmation of the rectal adenocarcinoma fulfilling the
- •following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of
- •carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3,
- •tumour budding, lymphatic and/or venous invasion.
- •5. Pathological confirmation of the rectal adenocarcinoma fulfilling the
- •following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate
- •differentiated and without tumour budding or lymphatic or venous invasion.
- •6. Complete colonoscopy, without synchronous colorectal cancer
- •7. cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be
- •considered as benign, independent of morphologic features. Staging done within
- •6 weeks before randomisation.
- •8. Adequate distant staging (X-thorax or CT-thorax and CT-abdomen) without
- •signs of distant metastasis (cM0)
- •9. Male or female, Age > 18 years.
- •10. Life expectancy of at least 12 months.
- •11. Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
- •12. No contraindications to chemotherapy, including adequate blood counts;
- •- white blood count >= 4.0 x 10 9/l
- •- platelet count >=100 x 109/l
- •- clinical acceptable haemoglobin levels
- •- bilirubin < 35 umol/l
- •- creatinine levels indicating renal clearance of >=50 ml/min
- •13. The patient is willing and able to comply with the protocol for the
- •duration of the study, and scheduled follow-up visits and examinations.
- •14. Written (signed and dated) informed consent and be capable of co-operating
- •with protocol.
排除标准
- •1. Incomplete or inconclusive resection margin with macroscopic residual tumour.
- •2. T1 tumour with carcinoma < 3 cm, moderate/well differentiated, without
- •sm3/Haggit 4,tumour budding, venous or lymphatic invasion.
- •3. T1 tumour with carcinoma of >5 cm and T2 tumour with carcinoma of > 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 that interferes with the outcomes within 28 days prior to
- •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 hepatic impairment.
- •14. Medical or psychiatric conditions that compromise the patient's ability to
- •give informed consent.
- •15. Patients known with dihydropyrimidine dehydrogenase deficiency.
- •16. Any contra-indications to undergo MRI imaging.
研究者
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