A prospective, multicentre, randomised trial of carboplatin flat dosing vs. intrapatient dose escalation in first line chemotherapy of ovarian, fallopian tube and primary peritoneal cancers

niversity of Glasgow (UK)0 个研究点目标入组 1,300 人开始时间: 2004年4月21日最近更新: 2018年11月12日

适应症

试验速览

•Current information as of 11/08/09:
•1. Patients with histologically confirmed epithelial ovarian carcinoma, or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy. Patients with peritoneal carcinomatosis (ovarian-type) are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting (see exclusion criteria).
•2. Female, aged 18 or over.
•3. FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy. Stage Ic patients will be limited to those with malignant cells in ascitic fluid/peritoneal washings, tumour on the surface of the ovary, or pre-operative capsule rupture.
•4. Written informed consent
•5. Can comply with follow up requirements
•6. Intention to treat patient within 8 weeks of initial surgery.
•Initial information at time of registration:
•Patients with histologically confirmed epithelial ovarian carcinoma (stage IC - IV), or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy

•Added 11/08/09:
•1. ECOG performance > 3
•2. Prior treatment with chemotherapy and radiotherapy
•3. Inadequate bone marrow function defined as neutrophils < 1.5 or plateles < 100
•4. Inadequate renal function as defined by calculated creatinine clearance (Cockcroft-Gault) of < 30ml/min. Obstructive hydronephrosis as a cause of borderline (eg 30-45 ml/min) renal function should be investigated and treated prior to study entry.
•5. Inadequate liver function as defined by bilirubin > upper limit of normal or AST/ALT >2.5 x upper limit of normal or ALP > 5 x upper limit of normal.
•6. Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure)
•7. Patient with mixed mesodermal tumours
•8. Patients with boderline ovarian tumours or tumours termed possibly malignant
•9. Adenocarcinoma of unknown origin, if histologically shown

发起方

niversity of Glasgow (UK)