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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005218-35-SE

Enrollment

Registered

2006-03-09

Start date

2006-05-18

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Locally advanced (FIGO III & IVa or stage II unfavorably located lesion) or relapsed vulvar carcinoma.

Interventions

Trade Name: Cisplatin-Platinol Product Name: cisplatin-platinol Product Code: cisplatin Pharmaceutical Form: Intravenous infusion INN or Proposed INN: cisplatin Concentration unit: mg/ml milligram(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the infield disease control of radiotherapy and concomittant cisplatin in patients with locally advanced (FIGO III &IVa or unfavorably located lesion) or relapsed vulva cancer.;Secondary Objective: Toxicity, time to progression, overall survival.;Primary end point(s): Infield disease control.	—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026