ISRCTN60597075已完成不适用
An Improvement of tumor regression with a cancer-risk modulated Radiochemotherapy In local advanced rectal cancer (LARC) can avoid the need for major Surgery: a phase II study
Regional Health and Social Agency (Agenzia Sanitaria e sociale Regionale- Regione Emilia Romagna) (Italy)0 个研究点目标入组 44 人开始时间: 2013年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
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
- 性别
- All
入选标准
- •1. Patients (aged above 18) with histological proven adenocarcinoma of the distal part of the rectum (between 3 and 10 cm from anal verge)
- •2. T2-3 tumour without lymph nodes > 1.5 cm and/or lateral pelvic lymph nodes > 1 cm at MRI and/or endoanal ultrasound
- •3. Tumour size less than or equal to 5 cm
- •4. No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required
- •5. Absolute Neutrophil Count (ANC) more than 1.5 x 109/l
- •6. Thrombocytes > 100 x 109/l
- •7. Creatinin clearance >50ml/min (according to the Cockcroft-Gault formula)
- •8. Total serum bilirubin < 24 mol/l or below <1.5 times the upper limit of the normal
- •9. Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT): up to 5 times the upper limit
- •10. Colonoscopy or virtual colonoscopy should exclude synchronous colorectal lesions in other parts of the colon
- •11. Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •12. Fertile women should have adequate birth control during treatment
- •13. Mental/physical/geographical ability to undergo treatment and follow-up
- •14. Written informed consent (Italian language)
排除标准
- •1. Preoperative staging by pelvic MRI and/or EUS of any cT1, any cT4, or cT2, N0.
- •2. Patients with circumferential rectal tumor or tumors who are by other means unacceptable for TEM surgery (e.g. intra anal tumors, tumors within 3mm of mesorectal fascia).
- •3. Tumours which are mucinous (>50% mucin seen on MRI), as these are more likely to be PET negative.
- •4. Patients with faecal incontinence prior to the diagnosis of rectal cancer (complaints of soiling due to the tumor will not be an exclusion criterium).
- •5. Any contra-indication to MRI scanning
- •6. Severe uncontrollable medical or neurological disease.
- •7. Patients with secondary prognosis determining malignancies.
- •8. Patients who have been treated with radiotherapy on the pelvis.
- •9. Fenytoine and Allopurinol use.
- •10. Known DPD deficiency
- •11. Uncontrolled active infection,immune status, psychosis, or CNS disease.
- •12. Pregnant or lactating women.
- •13. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months prior to treatment), myocardial infarction (= 6 months prior to treatment),
- •14. Unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
- •15. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Capecitabine or patients at high risk for treatment complications.
- •16. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy).
研究者
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