The efficacy and safety of concurrent chemoradiotherapy for squamous cell carcinoma of the vulva. Phase II Study

UMIN ID: UMIN000013439

Registered date:18/03/2014

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Vulva cancer
• Date of first enrollment: 2014/03/18
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Radiotherapy; Irradiation amount to the vulva is less than a total dose of 65Gy consisting of extra beam radiation of a fraction dose of 1.2-2 Gy per day in 5 times a week. In the case with definitely pelvic and inguinal lymph node metastasis, whole pelvis irradiation of a total 50 Gy, and inguinal lymph node irradiation of a total 65Gy are added. Chemotherapy: Nedaplatin is administered weekly at a dose of 30mg/m2 for 6 weeks.

Outcome(s)

• Primary Outcome: Local control rate
• Secondary Outcome: Progression free survival, Overall survival rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Female
• Exclude criteria: 1. History of chemotherapy or radiotherapy 2. Active double cancer 3. Active infection 4. Severe complicating illness ( bronchial asthma, pneumonia, ischemic heart disease, diabetes mellitus, arrhythmia) 5. Massive ascites or pleural fluid 6. History of severe allergic reaction 7. pregnant, lactating women and women who expects pregnant 8. Difficult case to keep the regulations and observations 9. Other reason that primary doctor think ineligible

Related Information

• Primary Sponsor: TGCU(Tohoku Gynecological Cancer Unit)
• Source(s) of Monetary Support: TGCU(Tohoku Gynecological Cancer Unit)