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

Phase 2

Completed

• Conditions: vulvar cancer; vulvar neoplasm; 10038597; 10029903

• Registration Number: NL-OMON30199
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

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

Exclusion Criteria

none

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to gain experience with primary radiochemotherapy and<br /><br>to determine the locoregional response rate at 12 weeks after radiochemotherapy<br /><br>and after groin dissection for cN1,2 patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective would be to determine short-term morbidity defined as<br /><br>desquamation of the skin, infection, long-term morbidity defined as edema,<br /><br>fibrosis, the incidence of fecal and or urinary continence, and or incidence of<br /><br>reconstructive surgery performed and treatment related mortality. Longterm<br /><br>morbidity and the rate of locoregional recurrences will be evaluated at 24<br /><br>months after the end of radiochemotherapy.</p><br>