Phase II study of definitive radiochemotherapy for locally advanced squamous cell cancer of the vulva: an efficacy study - radiotherapy for vulvar cancer

Koningin Wilhelmina Fonds0 个研究点开始时间: 2006年9月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•squamous cell cancer of the vulva with locally advanced disease not curable with surgery unless extensive reconstructive surgery or a colostomy or urostomy is performed
•Amenable to curative treatment
•No disease present outside the pelvis
•Performance status WHO 0-2
•Patients must be fit enough to undergo salvage surgery after chemo radiotherapy
•Measurable disease at least locally (vulvar area)
•Pretreatment laboratory values:
•- Hb> 6.5 mmol/l
•- Neutrophil count> 1.5 x 109/l
•- Platelets = 100 x 109/l
•- Bilirubin < 25µmol/l
•- Adequate liver function: ALAT and ASAT < 2.5 upper normal limit
•- Alkaline phosphatase < 2.5 upper normal limit
•No upper age limit specified. Patients should mentally, physically and geographically be able to undergo treatment and follow-up
•Patients must be > 18 years old
•Written informed consent
•No psychosis, CNS disease or other expected difficulty for follow-up
•No active uncontrolled infection
•No concomitant or previous malignancy other than basal cell carcinoma of the skin or CIN of the cervix
•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

发起方

Koningin Wilhelmina Fonds