A phase II study of management of the patients with locally advanced (FIGO III & IVa or stage II unfavorably located lesion) or relapsed vulvar carcinoma

ordic Society of Gynecological Oncology (NSGO)0 个研究点目标入组 50 人开始时间: 2006年3月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Patients with locally advanced (FIGO III & IVa or stage II unfavorably located lesion) or relapsed vulvar carcinoma found fit for curative treatment.
•2. No prior chemo or radiotherapy
•3. Histologically verified squamous carcinoma.
•4. At least one measurable target lesion.
•5. Age 18 and over
•6. Performance status WHO 0,1 or 2
•7. Acceptable bone marrow function and renal function.
•8. Signed written informed consent.
•9. Life expectancy of at least 3 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Other malignant disease except in situ carcionoma of the uterine cervix and basal cell carcinoma of the skin.
•2. Patients with pathological lymph nodes outside the regional area except enlarged nodes in the pelvis but not above arteria iliaca bifurcation niveau.
•3. Abnormal organ function, or as judged by the investigator, any evidence of severe or uncontrolled systemic disease.
•4. Serum creatinine clearance < 50ml/min
•5. Prior chemo or radiotherapy or concomittant antineoplastic treatment outside protocol.
•6. Active infection.
•7. Pregnant or breast feeding.

发起方

ordic Society of Gynecological Oncology (NSGO)