INNOVA: INterval or NeOadjuVAnt chemotherapy in rectal cancer. A phase II randomized study comparing interval versus neoadjuvant chemotherapy in magnetic resonance imaging-defined high risk rectal cancer - INNOVA

Cancer Institute WIA0 个研究点目标入组 94 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•â??Histopathologically confirmed adenocarcinoma of the lower and middle third rectum, with the lower edge of the tumor within 12 cm from the anal verge
•â??Age 18 to 70 years
•â??ECOG performance status 0-2
•â??Locally advanced tumor defined as presence of any one of the following on high-resolution thin slice (3mm) MRI:
•-Involved or threatened CRM (tumor or node extends to <=2mm of or beyond the mesorectal fascia)
•-Any T3 tumor in the lower rectum (within 6 cm from anal verge), T3c or T3d in mid rectum (ie-tumor extending >5mm beyond the muscularis propria)
•-Resectable T4
•-T3/T4 N1 or T1-T4 N2
•-Extramural vascular invasion
•â??No evidence of established distant metastasis
•â??Adequate haematological, liver and renal function (WBC >3 x 109/L, neutrophils >1.5 x 109/l and platelets >100 x 109/L; serum creatinine <=1 x upper limit of normal or creatinine clearance >50ml/min; serum bilirubin <1.5 x upper limit normal and liver transaminases and alkaline phosphatase <3 x upper limit normal)
•â??Normal clinical cardiovascular assessment
•â??Willing and able to give informed consent and comply with treatment schedule

•â??Disease outside the mesorectal envelope (internal iliac/ lateral pelvic lymph nodes)
•â??Previous radiotherapy to the pelvis
•â??Previously received chemotherapy for the currently diagnosed cancer
•â??Synchronous colorectal or other malignancies
•â??Active stable or unstable angina, NYHA class 2 congestive cardiac failure, myocardial infarction in the past 1 year, acute coronary syndrome even if controlled, arrhythmias
•â??Serious uncontrolled intercurrent illness including uncontrolled hypertension or poorly controlled diabetes mellitus
•â??Patients with a history of previous malignancy in the past 5 years, excepting basal or squamous cell skin cancer or cervical carcinoma-in-situ.
•â??Known HIV, HBV or HCV infection
•â??Pregnant or lactating women or premenopausal women not using adequate contraception
•â??Patients with any other condition or concurrent medical or psychiatric disease who, in the opinion of the investigator, is not eligible to enter the study

发起方