Phase II study of fixed dose rate Gemcitabine-Oxaliplatin Integrated with concomitant 5FU and 3-D Conformal Radiotherapy for the treatment of localised pancreatic cancer: GOFURTGO

AGITG0 个研究点目标入组 45 人开始时间: 2005年7月19日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Patient must have histologically/cytologically proven adenocarcinoma of the pancreas located in the head or the body of the pancreas (primary) or in the pancreatic bed (locally recurrent).Locoregional disease must be confirmed by dual phase CT (arterial and portal phases) without distant metastases (confirmed by CT of the chest, abdomen and pelvis).Patients must be assessed by a surgeon and considered inoperable.Performance status must be ECOG grade 0, 1 or 2.

•1.Histological types other than pancreatic ductal adenocarcinoma
•2. Metastatic disease.
•3. Tumours of the tail of pancreas
•4. Major co-morbid illnesses that, in the opinion of the investigator, would jeopardise the likely completion of the treatment program
•5. Patients with peripheral sensory neuropathy with functional impairment.
•6. Derangement of LFTs consistent with hepatic cellular dysfunction (ALT and/or AST >3 times upper limit of normal), or a bilirubin >3 times upper limit of normal. Patients with LFTs consistent with hepatic obstruction that is relieved (eg. by stenting, bypass) are eligible, provided the bilirubin has fallen to <3 times upper limit of normal.
•7. Patients with significant loss of bodyweight, who, at the investigator’s discretion, is deemed not suitable for this study (eg.>15% weight loss since surgery or diagnosis)
•8. Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
•9. Treatment with any previous cytotoxic chemotherapy for this malignancy. Previous hormonal manipulation (including HRT) is allowed.
•10. Previous abdominal radiotherapy
•11. A previous history of malignancy other than non-melanomatous skin cancers, in –situ carcinoma, or patients who are disease–free from non-pancreatic tumours treated definitively more than 5 years ago.
•12. Pregnant or lactating women, or women of childbearing potential not using adequate contraception.

发起方

AGITG