A prospective, single arm, multi-centre study of post neoadjuvant chemoradiation PET as predictor of pathological response in patients with localised oesophageal cancer

Dr Ariyanto Pramana0 个研究点目标入组 69 人开始时间: 2014年6月26日最近更新: 2022年10月16日

适应症

试验速览

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•Age greater than or equal to 18 years
•Surgically resectable carcinoma of oesophagus (PET staged T1-3, N0-1, M0)
•No invasion of the tracheobronchial tree
•Tumour must not extend greater than 2cm into the stomach
•ECOG between 0 and 2
•Patients must have adequate haematological, renal, hepatic, and pulmonary functions defined as: granulocytes greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 100 x 10^9/L, total bilirubin less than or equal to 1.5 x upper normal limit, and creatinine clearance greater than or equal to 50ml/min
•Non-English speaking background patient is allowed as long as interpreter service is provided during the enrolment, treatment, and follow up phase

•Past or current history of malignancy other than entry diagnosis
•-History of another malignancy within 5 years prior to registration. Participants with curatively treated cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or superficial bladder tumours (T1a[Non-invasive tumour], and Tis[Carcinoma in situ]), or participants who have been free of other malignancies for greater than or equal to 5 years prior to enrolment are eligible for this study
•Previous chemotherapy or radiotherapy
•Myocardial infarct in last 6 months
•Congestive heart failure or uncontrolled arrhythmia
•Neurotoxicity grade greater than 1
•Uncontrolled diabetes mellitus despite maximum therapy
•Pregnancy, lactation or inadequate contraception
•Known allergic reaction to FDG PET contrast

发起方

Dr Ariyanto Pramana