Locally Advanced Vulvar CarcinomaPhase 2VULCANIZE-IINCT05905315
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
A Phase 2 study testing Paclitaxel and Carboplatin and Chemoradiation in people with Locally Advanced Vulvar Carcinoma and Squamous Cell Carcinoma of the Vulva, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Vulvar Carcinoma, Squamous Cell Carcinoma of the Vulva
- What is being tested?
- Paclitaxel and Carboplatin and Chemoradiation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2024to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 surgery). This can imply;
- 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
Show all 12Show fewer
- 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 subjects
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
NKI-AVL
Amsterdam
F. Amant
- Recruiting
LUMC
Leiden
L. Nooij
About this study
Official title: Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma
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.
- Being tested
- Paclitaxel and Carboplatin, Chemoradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel and CarboplatinDrug
Paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme.
ChemoradiationCombination product
According to standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| Primary chemoradiation | Active comparator | Patients included in the standard treatment arm will receive a combination of weekly cisplatin combined with 30 fractions of external beam radiotherapy on the primary tumour with a total dose of 64.5 Gy. Cisplatin will be given for six weeks intravenously with a dose of 40 mg/m2, if possible on the first day of the week. On day 1 until day 5 the patient will receive external beam radiotherapy. This will be repeated for a six-week period. Receives: Combination Product: Chemoradiation |
| NACT (3-weekly carboplatin and paclitaxel) followed by surgery | Experimental | Patients included in the experimental arm will be treated with intravenous infusion of paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme with preferably 3 and a maximum of 4 courses, with evaluation after two courses of chemotherapy by physical examination. NACT will be subsequently followed by radical surgery in responding patients. A four to six weeks interval after the last course of chemotherapy needs to be respected before surgery, to allow sufficient physical recovery. Receives: Drug: Paclitaxel and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco-regional control after 24 months per completed treatment including salvage treatment
Proportion of patients free from local-regional progression
Measured: 24 months after completed treatment
Secondary outcomes (8)
Disease-related treatment failure
Patients without an event will be censored at their last date of contact. The Kaplan-Meier method will be used to estimate freedom from disease-related failure. Difference between the two main treatment arms, NACT vs. chemotherapy, will be tested using a log-rank test. Incidences of disease-related failure will be reported based on the Kaplan-Meier estimates, together with confidence intervals for the hazard ratio using both 90 and 95% confidence levels.
Measured: 24 months after completed treatment
Disease free survival
Measured: 24 months after completed treatment
Patterns of recurrence of disease
Type of recurrence after treatment: local, regional or distant recurrence
Measured: 24 months after completed treatment
Overall survival
Measured: 24 months after completed treatment
Treatment related death
Measured: 24 months after completed treatment
Prevention of trimodal treatment
Proportion of patients that don't need adjuvant surgery (arm 1) and number of patients that don't need adjuvant radiotherapy (arm 2)
Measured: 24 months after completed treatment
Functional organ preservation
Proportion of patients for who an organ-sparing surgery is possible
Measured: 24 months after completed treatment
Short term and long term complications
According to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 24 months after completed treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Vulvar CarcinomaStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Amant, Prof., Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905315
- Sponsor's protocol ID
- M22VL2
- Acronym
- VULCANIZE-II
- Status last verified
- Apr 2024
- First submitted
- 12 Dec 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amant F, van Velzen AF, Reyners A, Zijlmans H, Schaake EE, Nooij L. Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2). Int J Gynecol Cancer. 2024 Oct 7;34(10):1639-1642. doi: 10.1136/ijgc-2024-005493.
PubMed 38719277
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma
- ClinicalTrials.gov ID
- NCT05905315
- Acronym / sponsor ID
- VULCANIZE-II / M22VL2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary chemoradiation | Active comparator | Combination Product: ChemoradiationPatients included in the standard treatment arm will receive a combination of weekly cisplatin combined with 30 fractions of external beam radiotherapy on the primary tumour with a total dose of 64.5 Gy. Cisplatin will be given for six weeks intravenously with a dose of 40 mg/m2, if possible on the first day of the week. On day 1 until day 5 the patient will receive external beam radiotherapy. This will be repeated for a six-week period. |
| NACT (3-weekly carboplatin and paclitaxel) followed by surgery | Experimental | Drug: Paclitaxel and CarboplatinPatients included in the experimental arm will be treated with intravenous infusion of paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme with preferably 3 and a maximum of 4 courses, with evaluation after two courses of chemotherapy by physical examination. NACT will be subsequently followed by radical surgery in responding patients. A four to six weeks interval after the last course of chemotherapy needs to be respected before surgery, to allow sufficient physical recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 surgery). This can imply;
- World Health Organization performance status of 0-2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel and CarboplatinPaclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme. | Drug | NACT (3-weekly carboplatin and paclitaxel) followed by surgery |
| ChemoradiationAccording to standard treatment. | Combination product | Primary chemoradiation |
Primary outcome
Loco-regional control after 24 months per completed treatment including salvage treatment
Time frame: 24 months after completed treatment
Proportion of patients free from local-regional progression
8 secondary outcomes
Disease-related treatment failure
Time frame: 24 months after completed treatment
Disease free survival
Time frame: 24 months after completed treatment
Patterns of recurrence of disease
Time frame: 24 months after completed treatment
Overall survival
Time frame: 24 months after completed treatment
Treatment related death
Time frame: 24 months after completed treatment
Prevention of trimodal treatment
Time frame: 24 months after completed treatment
Functional organ preservation
Time frame: 24 months after completed treatment
Short term and long term complications
Time frame: 24 months after completed treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 38719277Amant F, van Velzen AF, Reyners A, Zijlmans H, Schaake EE, Nooij L. Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2). Int J Gynecol Cancer. 2024 Oct 7;34(10):1639-1642. doi: 10.1136/ijgc-2024-005493.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederic Amant, Prof. principal investigator
The Netherlands Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Carboplatin and Chemoradiation in people with Locally Advanced Vulvar Carcinoma and Squamous Cell Carcinoma of the Vulva, run by The Netherlands Cancer Institute at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederic Amant, Prof. (0031205129111, f.amant@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loco-regional control after 24 months per completed treatment including salvage treatment (time frame: 24 months after completed treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05905315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.