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New treatment option for Locally Advanced Vulvar Carcinoma
Official title Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
ClinicalTrials.gov ID: NCT05905315
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 locally advanced vulvar carcinoma.
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
- A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib - IVa, T1b or higher, any N, M0.
- Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of...
- T1b or larger tumour with (irresectable) groin metastases
You likely can't join if
- Patients with highly suspicious or positive metastases to the pelvic lymph nodes \ Patients eligible for radical local excision without involvement...
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol
- Existing neuropathy which will hinder the intake of chemotherapy
See the full eligibility criteria
- Woman ≥ 18 years
- Signed and written informed consent.
- Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib - IVa, T1b or higher, any N, M0.
- Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative...
- T1b or larger tumour with (irresectable) groin metastases
- T1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter
- World Health Organization performance status of 0-2
- Adequate haematological function defined by platelet count \>100x10E9/L, absolute leukocyte \>3X10E9/L or neutrophil count (ANC) \>1.5x10E9/L, and hemoglobin \>6.0 mmol/L
- Adequate hepatic function defined by a total bilirubin level ≤1.5x the upper limit of normal (ULN) range and ASAT and ALAT levels ≤2.5x ULN for all people
- Adequate renal function defined by an estimated creatinine clearance ≥50mL/min according to the Cockroft-Gault formula (or local institutional standard method)
- Beta HCG level of 14 mIU/mL or below for women of childbearing potential
- Highly effective contraception for patients if the risk of conception exists
- Patients with highly suspicious or positive metastases to the pelvic lymph nodes \ Patients eligible for radical local excision without involvement of other organs
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol
- Existing neuropathy which will hinder the intake of chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Leiden, 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; Leiden, 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.