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

• Conditions: advanced stage squamous cell cancer of the vulva; MedDRA version: 8.1Level: LLTClassification code 10047777Term: Vulvar cancer

• Registration Number: EUCTR2006-004052-20-NL
• Lead Sponsor: Koningin Wilhelmina Fonds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

none

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to gain experience with primary radiochemotherapy and to determine the locoregional response rate at 12 weeks after radiochemotherapy and after groin dissection for cN1,2 patients.;Secondary Objective: The secondary objective would be to determine short-term morbidity defined as desquamation of the skin, infection, long-term morbidity defined as edema, fibrosis, the incidence of fecal and or urinary continence, and or incidence of reconstructive surgery performed and treatment related mortality. Longterm morbidity and the rate of locoregional recurrences will be evaluated at 24 months after the end of radiochemotherapy.;Primary end point(s): locoregional control rate defined as clinically or pathologically proven absence of tumor (CR according to RECIST criteria) in the vulvar area, groins and/or pelvis 12 weeks after the end of radiochemotherapy and after groin dissection in cN1,2 patients.