Clinical trial · Interventional
Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
NCT04192253CI-TRIAL-00061535VULCANizerecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced, Squamous Cell Carcinoma of the Vulva | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel and Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- neo-adjuvant Paclitaxel and Carboplatin
- description
- Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
- interventionNames
- Drug: Paclitaxel and Carboplatin
Primary outcomes (1)
- measure
- tumour size change by neoadjuvant chemotherapy
- timeFrame
- 18 weeks
- description
- tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1
Secondary outcomes (3)
- measure
- avoidance of exenterative or invalidating surgery
- timeFrame
- 21 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Woman k 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, MO 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
References
Publications (0)
Data not yet available
No reference posted for this study.