Trans Tasman Radiation Oncology Group (TROG) 03.01 - A randomised phase III study in advanced oesophageal cancer to compare quality of life and palliation of dysphagia in patients treated with radiotherapy versus chemo-radiotherapy (cisplatin & 5-Flurouracil).

Trans Tasman Radiation Oncology Group0 个研究点目标入组 220 人开始时间: 2003年12月22日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Biopsy proven carcinoma of the Oesophagus
•2. Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness (it should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment).
•3. Symptomatic patients with dysphagia scores of => 1 i.e. able to eat only some sollids (see appendix 1)
•4. Performance status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
•5. Patients msut begin treatment within 2 weeks of randomisation
•6. Patient is at least 18 years old
•7. Adequate haematology function to undergo chemotherapy Peripheral blood - Neutrophils > 1.5 x 109/L - Platelets > 100 x 109/L
•8. Adequate renal function, Creatine - Calculated clearence 50 ml/min (see appendix 1).
•9. Patients capable of child bearing are using adequate contraception.
•10. Written informed consent of patient.

•1. Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest.
•2. Synchronous active malignancies.
•3. Pregnant or lactating patients.
•4. Patients unfit for any treatment component.
•5. Tracheo-oesophageal fistula.
•6. Stents in situ.
•7. Previous chemotherapy for Oesophageal Cancer
•8. CT scan of thorax and abdomen more than 8 weeks prior to randomisation
•9. Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomisation

发起方

Trans Tasman Radiation Oncology Group