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New treatment option for Metastatic Squamous Cell Carcinoma of the Vulva
Official title Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy
ClinicalTrials.gov ID: NCT04161664
What this study is testing
What is Paclitaxel and Carboplatin?
Paclitaxel and Carboplatin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for metastatic squamous cell carcinoma of the vulva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma
- Measurable disease
- Lesion previously not irradiated
- TNM stage any T any N M1
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.