Locally Advanced, Squamous Cell Carcinoma of the VulvaPhase 2VULCANizeNCT04192253
Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
A Phase 2 study testing Paclitaxel and Carboplatin in people with Locally Advanced, Squamous Cell Carcinoma of the Vulva, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced, Squamous Cell Carcinoma of the Vulva
- What is being tested?
- Paclitaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jan 2020to 1 Jan 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 k 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
Show all 10Show fewer
- Adequate renal function
- Negative pregnancy test for woman of childbearing potential
- measurable disease by physical examination
- TNM stage T2, any N, MO
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
NKI-AVL
Amsterdam, 1066CX
NKI-AVL Zijlmans, MD, PhD, 0031205129111, h.zijlmans@nki.nl
Henry Zijlmans, MD, PhD
About this study
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 neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.
Read the detailed description
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 neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive, thereby diminishing the chance for morbidity.
- Being tested
- Paclitaxel and Carboplatin
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 and Carboplatin AUC 5 in a 3 weekly schedule
| Study group | Role | What they receive |
|---|---|---|
| neo-adjuvant Paclitaxel and Carboplatin | Experimental | Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule Receives: Drug: Paclitaxel and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumour size change by neoadjuvant chemotherapy
tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1
Measured: 18 weeks
Secondary outcomes (3)
avoidance of exenterative or invalidating surgery
number of patients were surgery can be reduced after the neo-adjuvant chemotherapy
Measured: 21 weeks
Chemotherapy related morbidity
Chemotherapy related morbidity measured by reported adverse events
Measured: 21 weeks
overall survival
overall survival
Measured: 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start14 Jan 2020
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced, Squamous Cell Carcinoma of the VulvaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- a prospective, phase ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Amant, MD, PHD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192253
- Sponsor's protocol ID
- M19VLC
- Acronym
- VULCANize
- Status last verified
- Oct 2022
- First submitted
- 11 Nov 2019
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
- ClinicalTrials.gov ID
- NCT04192253
- Acronym / sponsor ID
- VULCANize / M19VLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 10 Dec 2019 (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.
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 neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.
Detailed description
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 neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive, thereby diminishing the chance for morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a prospective, phase ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma
| Arm | Type | Receives |
|---|---|---|
| neo-adjuvant Paclitaxel and Carboplatin | Experimental | Drug: Paclitaxel and CarboplatinPaclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Woman k 18 years
- Signed and written informed consent.
- Histologically confirmed squamous cell vulvar carcinoma
- World Health Organization performance status of 0-2
- Adequate hematological function
Key exclusion criteria (4 listed)
- 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
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 and Carboplatin AUC 5 in a 3 weekly schedule | Drug | neo-adjuvant Paclitaxel and Carboplatin |
Primary outcome
tumour size change by neoadjuvant chemotherapy
Time frame: 18 weeks
tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1
3 secondary outcomes
avoidance of exenterative or invalidating surgery
Time frame: 21 weeks
Chemotherapy related morbidity
Time frame: 21 weeks
overall survival
Time frame: 5 years after 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 19 Oct 2022.
- 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, MD, PHD principal investigator
The Netherlands Cancer Institute
1 site 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 in people with Locally Advanced, Squamous Cell Carcinoma of the Vulva, run by The Netherlands Cancer Institute at 1 site 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 10 inclusion and 4 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 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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, MD, PhD (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?
tumour size change by neoadjuvant chemotherapy (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2022.