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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013439

Enrollment

Registered

2014-03-18

Start date

2014-03-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulva cancer

Interventions

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 in

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Squamous cell carcinoma of the vulva 2. The tumor had to be grossly measurable 3. Initial treatment case 4. Age between 20 and 80 years old 5. ECOG Performance status 0-1 6. Normal organ function (WBC>=3000/mm3, Neutrophil >=1500/mm3, Platelet 100,000/mm3, GOT(AST) and GPT(ALT) <=twice upper within limit, Total Bilirubin<1.5 mg/dL, Cre <= within upper limit, Ccr >= 60ml/min) 7. Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Local control rate	—

Secondary

Measure	Time frame
Progression free survival, Overall survival rate	—

Countries

Japan

Contacts

Public ContactMasayuki Futagami

TGCU(Tohoku Gynecological Cancer Unit) Department of Obstetrics & Gynecology

futagami@cc.hirosaki-u.ac.jp0172-39-5107

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026