NCT04161664 Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy
| NCT ID | NCT04161664 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Metastatic Squamous Cell Carcinoma of the Vulva |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2020-01-16 |
| Primary Completion | 2024-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2020-01-16 with a primary completion date of 2024-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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 * Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma * Measurable disease * Lesion previously not irradiated * TNM stage any T any N M1 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
Contact & Investigator
Frederic Amant, MD, PHD
PRINCIPAL INVESTIGATOR
NKI-AvL
Frequently Asked Questions
Who can join the NCT04161664 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Metastatic Squamous Cell Carcinoma of the Vulva. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04161664 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04161664 currently recruiting?
Yes, NCT04161664 is actively recruiting participants. Contact the research team at f.amant@nki.nl for enrollment information.
Where is the NCT04161664 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04161664 clinical trial?
NCT04161664 is sponsored by The Netherlands Cancer Institute. The principal investigator is Frederic Amant, MD, PHD at NKI-AvL. The trial plans to enroll 12 participants.