Phase II study of pre-operative treatment with external radiotherapy plus panitumumab in operable locally advanced rectal cancer (favourable and intermediate prognostic group) (RaP Study/STAR-03) - RaP/STAR-03 STUDY

FONDAZIONE DELL'ISTITUTO TOSCANO TUMORI0 个研究点目标入组 92 人开始时间: 2012年6月14日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•Histologically diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge); KRAS wild type; age =18 years; Karnofsky performance status of =70 at study entry; clinical stage T3 N- M0 or cT2-T3 N+ M0 - CRM; hemoglobin = 9 g/dl; neutrophils = 1.5 x 10^9/L; platelets = 100 x 10^9/L; bilirubin level < 1.5 ULN; ASAT and ALAT <= 2.5 x ULN; serum creatinine < 1.5 x ULN; magnesium = lower limit of normal; calcium = lower limit of normal; effective contraception for both, male and female patients if the risk of conception exists; signed and dated written informed consents
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 74
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•Prior radiotherapy or chemotherapy for rectal cancer; concurrent chronic systemic immune therapy; any investigational agent(s); previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy; clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months; known grade 3 or 4 allergic reaction to any of the components of the treatment; known drug abuse/ alcohol abuse; legal incapacity or limited legal capacity; medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed; women who are pregnant or breastfeeding consent; acute or subacute gastro-intestinal occlusion; any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the trial)

发起方

FONDAZIONE DELL'ISTITUTO TOSCANO TUMORI