Phase II study of up-front chemotherapy and neo-adjuvant short-course radiotherapy for resectable rectal carcinoma - COLORE

IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO0 个研究点目标入组 50 人开始时间: 2013年3月12日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•1.Patients with histologically or cytologically confirmed diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge)
•2.Stage: lowT2N0, T2N+M0, T3-4 N-/+M0 (N+ = = 3 nodes >0,5 cm diameter or = 1 nodes > 1 cm diameter)
•3.Age =18 and = 80 years
•4.ECOG performance status 0-1
•5.Patients must have normal organ and marrow function as defined below:
•a.- Leukocytes = 3,000/?L
•b.- Absolute neutrophil count = 1,500/?L
•c.- Platelets = 100,000/?L
•d.- Total bilirubin = 1.5 X ULN
•e.- AST (SGOT)/ALT (SGPT) = 2.5 X ULN
•f.- Creatinine = 1.5 X ULN
•6.Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
•7.Participant is willing and able to give informed consent for participation in the study.
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1.Metastatic disease
•2.Patients who have had any chemotherapy or radiotherapy prior to entering the study
•3.Acute or sub-acute gastrointestinal occlusion
•4.Participation in another clinical trial, with any investigational agent within 30 days prior the study screening
•5.Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma, superficial bladder tumor and in situ carcinoma of the uterine cervix)
•6.History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study
•7.Uncontrolled concomitant illness, including but not limited to: ongoing or active infections; congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance to study requirements

发起方

IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO