ORGAN SPARING FOR LOCALLY ADVANCED RECTAL CANCER AFTER NEOADJUVANT TREATMENT FOLLOWED BY ELECTROCHEMOTHERAPY

ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE0 个研究点目标入组 70 人开始时间: 2018年12月11日最近更新: 2020年9月7日

试验速览

暂无简介。

•a)Male or female patients aged > 18 years
•b)Histological confirmation of rectal adenocarcinoma
•c)Patients undergoing neoadjuvant treatment for locally advanced tumor of the rectum with confirmed major clinical response after neoadjuvant treatment
•d)Rectal tumor up to 12 cm from the external anal margin
•e)Patients must be willing to comply with the study protocol and give their informed written consent.
•f)Patients with an ECOG status performance <3
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 30

•a)Age less than 18 years
•b)Patients with neoplasia more than 12 cm from the anal margin
•c)Patients with stable disease or disease progression after neoadjuvant treatment
•d)Patients, who for medical reasons, cannot be given bleomycin
•e)Lesions not suitable for ECT (bony invasion, large vessels infiltration, etc.);
•f)Acute lung infection;
•g)Symptoms of poor lung function;
•h)Non correctable severe coagulation disorders;
•i)Previous allergic reactions to bleomycin;
•j)Previous cumulative dose of 250 mg/m2 of bleomycin exceeded;
•k)Chronic renal dysfunction (creatinine> 150 µmol/L must be considered a lower administered dose of bleomycin)
•l)Pregnancy or lactation**
•**Pregnancy has been established prior to enrolment by beta-HCG assay on urine (pregnancy test or urinary beta-HCG) or blood (plasma beta-HCG).

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