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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 neo adjuvant 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 neo adjuvant 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 | 6 courses of 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 | 6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumour size reduction by neo adjuvant chemotherapy | tumour size reduction measured by RECIST 1.1 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| chemotherapy related morbidity | chemotherapy related morbidity measured by number and grade of adverse events | 21 weeks |
| overall survival | overall survival |
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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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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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a prospective, phase II trial to investigate the response rate of carboplatin and paclitaxel in patients with vulvar carcinoma
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| 5 years after treatment |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |