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Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)
EU CTIS ID: 2022-502685-25-00
What this study is testing
The main objective of this trial is to compare the efficacy and safety of primary chemoradiation with neoadjuvant chemotherapy (NACT) followed by surgery in patients with LAVC.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Woman ≥ 18 years
- 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
- Highly effective contraception for patients if the risk of conception exists
- 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
You likely can't join if
- Patients with highly suspicious or positive metastases to the pelvic lymph nodes
- 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
- Patients eligible for radical local excision without involvement of other organs
- Contra-indication to paclitaxel, cisplatin or carboplatin as stated in the SmPC
See the full eligibility criteria
- Woman ≥ 18 years
- 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
- Highly effective contraception for patients if the risk of conception exists
- 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 surgery). This can imply: T1b or larger tumour with (irresectable) groin metastases. Or this can imply: 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 neutrophil count >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 range and ASAT and ALAT levels ≤2.5x ULN for all subjects
- Adequate renal function defined by an estimated creatinine clearance ≥50mL/min according to the Cockroft-Gault formula (or local institutional standard method)
- Patients with highly suspicious or positive metastases to the pelvic lymph nodes
- 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
- Patients eligible for radical local excision without involvement of other organs
- Contra-indication to paclitaxel, cisplatin or carboplatin as stated in the SmPC
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.