Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma using Peri-operative Chemotherapy with additional Pre-operative Combined Radiotherapy and Cetuximab - TRACC study

niversitair Medisch Centrum Utrecht0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•1) Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction ;2) Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gasto-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases.;3) Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained. Informed consent should be obtained before start of pre-operative chemotherapy treatment.;4) Weight loss < 10% in 0.5 yr;5) WHO performance status 0-1;6) No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus;7) Eligible for pre-operative chemotherapy as standard treatment for resectable adenocarcinoma of the lower oesophagus and gastro-oesophageal junction.

•1) Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ or any other malignancy with minimal chance of recurrence that has been treated with curative intent more than 5 years before start of study.
•2) Inadequate organ function as defined by:
•- Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils < 1,5 109/L -platelets <100*109/L),
•- Liver enzyme elevation (bili > 1,5*ULN - ASAT > 2,5*ULN * ALAT > 2,5*ULN) or
•- Impaired renal function (creatinine clearance by Cockroft < 60 cc/min)
•- Proteinuria >1,0gr/24hr or urine protein stick <2+
•3) Tumour stage: M1a and/or tumour length > 8 cm and/or > 5 cm radially
•4) Major surgery within 4 weeks prior to the start of study treatment
•5) Bleeding disorder
•6) Known allergy to cetuximab
•7) Previous radiotherapy to the chest
•8) Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
•9) Continuous use of immunosuppressive agents
•10) Prior exposure to anti-EGFR targeting agents.
•11) Pregnancy or breast feeding
•12) Patients (M/F) with reproductive potential not implementing adequate contraceptive measures

发起方

niversitair Medisch Centrum Utrecht