Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Jan 2024 → ongoing

Decision date (initial)

2025-04-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 2

1. Secondary objectives of this trial are to compare the quality of life (QoL) of patients with LAVC after primary chemoradiation with patients treated with NACT followed by surgery.
2. Determine the effect of human papillomavirus (HPV) status on treatment response.

Conditions and MedDRA coding

The trial population will consist of patients with LAVC who require primary chemoradiation or extensive surgery damaging pelvic organs or exenterative surgery.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Woman ≥ 18 years
2. Highly effective contraception for patients if the risk of conception exists
3. Signed and written informed consent
4. Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib – IVa, T1b or higher, any N, M0
5. 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
6. World Health Organization performance status of 0‐2
7. Adequate haematological function defined by platelet count >100x10E9/L, absolute neutrophil count >1.5x10E9/L, and hemoglobin >6.0 mmol/L
8. 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
9. Adequate renal function defined by an estimated creatinine clearance ≥50mL/min according to the Cockroft-Gault formula (or local institutional standard method)
10. Beta HCG level of 14 mIU/mL or below for women of childbearing potential
11. Highly effective contraception for patients if the risk of conception exists

Exclusion criteria 6

1. Patients with highly suspicious or positive metastases to the pelvic lymph nodes
2. Any psychiatric condition that would prohibit the understanding or rendering of informed consent
3. Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol
4. Existing neuropathy which will hinder the intake of chemotherapy
5. Patients eligible for radical local excision without involvement of other organs
6. Contra-indication to paclitaxel, cisplatin or carboplatin as stated in the SmPC

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is loco‐regional control at 2 years per arm, including salvage or adjuvant treatments

Secondary endpoints 10

1. Morbidity
2. Disease-related treatment failure
3. Disease-free survival
4. Prevention of trimodal treatment (surgery and chemotherapy and radiotherapy)
5. functional organ preservation
6. Quality of life
7. Treatment-related morbidity
8. death
9. Complications
10. Influence of HPV status on treatment outcome

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Sponsor organisation

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Contact name

Departement of Biometrics

Public contact point

Organisation

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis

Contact name

Departement of Biometrics

Locations

4 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 36 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications