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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neo-adjuvant Paclitaxel and Carboplatin | Experimental | Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel and Carboplatin | Drug | Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumour size change by neoadjuvant chemotherapy | tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| avoidance of exenterative or invalidating surgery | number of patients were surgery can be reduced after the neo-adjuvant chemotherapy | 21 weeks |
| Chemotherapy related morbidity | Chemotherapy related morbidity measured by reported adverse events |
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Inclusion Criteria:
Exclusion Criteria:
vulva carcinoma
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederic Amant, MD, PhD | Contact | 0031205129111 | f.amant@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Frederic Amant, MD, PHD | NKI-AvL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKI-AVL | Recruiting | Amsterdam | 1066CX | Netherlands |
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a prospective, phase ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma
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| 21 weeks |
| overall survival | overall survival | 5 years after treatment |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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