Treatment of locally advanced VULvar CArcinoma in a Neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy

Treatment of locally advanced VULvar CArcinoma in a Neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy - VULCANize

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003104-12-NL

Enrollment

Registered

2019-11-26

Start date

2020-01-14

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

vulvar carcinoma MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Paclitaxel Product Name: paclitaxel Product Code: L01CD01 Pharmaceutical Form: Infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Trade Name: Carboplatin Product Name: carbop

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Woman = 18 years • Signed and written informed consent. • Histologically confirmed squamous cell vulvar carcinoma • World Health Organization performance status of 0-2 • Adequate hematological function • Adequate hepatic function • Adequate renal function • Negative pregnancy test for woman of childbearing potential • measurable disease by physical examination • TNM stage T2, any N, M0 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 41

Exclusion criteria

Exclusion criteria: • Vulvar cancer other than squamous cell carcinoma at biopsy • Previous radiotherapy of the vulva, groins or pelvis • Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent • Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study

Design outcomes

Primary

Measure	Time frame
Main Objective: Response rate and tumour size reduction after neoadjuvant chemotherapy according to RECIST 1.1 and possibility for down staging and avoidance of exenterative surgery ;Secondary Objective: local control of the vulva, disease free survival and overall survival, pattern of recurrence and evaluation of microscopic response translational research to predict response to neoadjuvant chemotherapy and microscopic response;Primary end point(s): response rate of carboplatin and paclitaxel;Timepoint(s) of evaluation of this end point: after 3 cycles of treatment	—

Measure

Time frame

Main Objective: Response rate and tumour size reduction after neoadjuvant chemotherapy according to RECIST 1.1 and possibility for down staging and avoidance of exenterative surgery ;Secondary Objective: local control of the vulva, disease free survival and overall survival, pattern of recurrence and evaluation of microscopic response translational research to predict response to neoadjuvant chemotherapy and microscopic response;Primary end point(s): response rate of carboplatin and paclitaxel;Timepoint(s) of evaluation of this end point: after 3 cycles of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): local control of the vulva, disease free survival and overall survival pattern of recurrence and evaluation of microscopic response translational research to predict response to neoadjuvant chemotherapy and microscopic response;Timepoint(s) of evaluation of this end point: after follow-up (5 years)	—

Countries

Netherlands

Contacts

Public ContactHenry Zijlmans

NKI-AVL

h.zijlmans@nki.nl00310205129111

Outcome results

None listed

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