BALLAD - A trial to evaluate the potential benefit of adjuvantchemotherapy for small bowel adenocarcinoma. - BALLAD

Greater Glasgow and Clyde Health Board0 个研究点目标入组 580 人开始时间: 2018年9月17日最近更新: 2022年2月1日

试验速览

暂无简介。

•1.R0 resected stage I, II or III small bowel adenocarcinoma
•2.No evidence of residual or metastatic disease at laparotomy and on CT/MRI imaging of chest, abdomen and pelvis.
•3.Patients must be registered and randomised within 12 weeks of surgery and commence chemotherapy within 14 weeks of surgery
•4.ECOG Performance Status of 0 or 1
•5.Absolute neutrophil count of = 1.5 x10(9)/l
•6.Platelet count = 100 x 10 (9)/l
•7.Haemoglobin = 90 g/l (previous transfusion is allowed)
•8. AST and ALT = 2.5 x upper limit of normal (ULN). (At least one of ALT or AST MUST be performed)
•9.Creatinine clearance > 50 ml/min (calculated by Cockcroft Gault or Wright equation) or measured by EDTA
•10.Serum bilirubin = 1.5 x ULN
•11.Signed and dated informed consent indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment.
•12.Age = 16 years
•13.Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures.
•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 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1.Non-adenocarcinoma histology of small bowel tumour which includes but is not confined to lymphoma, GIST, carcinoid or other neuroendocrine tumour, squamous carcinoma, melanoma or sarcoma.
•2.Previous neo-adjuvant chemo(radio)therapy for small bowel adenocarcinoma
•3.Clinically significant cardiovascular disease (i.e. active or < 12 months since cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association [NYHA] grade II or greater, congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension)
•4.Pregnancy/lactation or of child bearing potential and not using medically approved contraception. (Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
•5.Previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 3 years and treatment was with curative intent
•6.Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
•7.Known untreated coeliac disease (may be enrolled if diet controlled), untreated chronic inflammatory bowel disease or other cause of malabsorption or intestinal obstruction
•8.Grade = 2 peripheral neuropathy
•9.Administration of any investigational drug within 28 days or 5 half lives, whichever is longer, prior to receiving the first dose of trial treatment

发起方

Greater Glasgow and Clyde Health Board