A phase II study of management of the patients with locally advanced (FIGO III & IVa or stage II unfavorably located lesion) or relapsed vulvar carcinoma

ordic Society of Gynecological Oncology (NSGO)0 sites50 target enrollmentMarch 9, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ocally advanced (FIGO III & IVa or stage II unfavorably located lesion) or relapsed vulvar carcinoma.
Sponsor: ordic Society of Gynecological Oncology (NSGO)
Enrollment: 50
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 9, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

ordic Society of Gynecological Oncology (NSGO)

•1\. Patients with locally advanced (FIGO III \& IVa or stage II unfavorably located lesion) or relapsed vulvar carcinoma found fit for curative treatment.
•2\. No prior chemo or radiotherapy
•3\. Histologically verified squamous carcinoma.
•4\. At least one measurable target lesion.
•5\. Age 18 and over
•6\. Performance status WHO 0,1 or 2
•7\. Acceptable bone marrow function and renal function.
•8\. Signed written informed consent.
•9\. Life expectancy of at least 3 months.
•Are the trial subjects under 18? no

•1\. Other malignant disease except in situ carcionoma of the uterine cervix and basal cell carcinoma of the skin.
•2\. Patients with pathological lymph nodes outside the regional area except enlarged nodes in the pelvis but not above arteria iliaca bifurcation niveau.
•3\. Abnormal organ function, or as judged by the investigator, any evidence of severe or uncontrolled systemic disease.
•4\. Serum creatinine clearance \< 50ml/min
•5\. Prior chemo or radiotherapy or concomittant antineoplastic treatment outside protocol.
•6\. Active infection.
•7\. Pregnant or breast feeding.