NCT04161664

Brief 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. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
32mo left

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2020Jan 2029

First Submitted

Initial submission to the registry

November 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Expected
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

November 11, 2019

Last Update Submit

October 18, 2022

Conditions

Metastatic Squamous Cell Carcinoma of the Vulva

Outcome Measures

Primary Outcomes (1)

  • tumour size reduction by neo adjuvant chemotherapy

    tumour size reduction measured by RECIST 1.1

    18 weeks

Secondary Outcomes (2)

  • chemotherapy related morbidity

    21 weeks

  • overall survival

    5 years after treatment

Study Arms (1)

neo adjuvant Paclitaxel and Carboplatin

EXPERIMENTAL

6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

Drug: Paclitaxel and Carboplatin

Interventions

Paclitaxel and CarboplatinDRUG

6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

neo adjuvant Paclitaxel and Carboplatin

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsvulva carcinoma
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman 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
  • Adequate renal function
  • Negative pregnancy test for woman of childbearing potential
  • Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma
  • Measurable disease
  • Lesion previously not irradiated
  • TNM stage any T any N M1

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NKI-AVL

Amsterdam, 1066CX, Netherlands

RECRUITING

MeSH Terms

Interventions

PaclitaxelCarboplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Frederic Amant, MD, PHD

    NKI-AvL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic Amant, MD, PhD

CONTACT

0031205129111f.amant@nki.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: a prospective, phase II trial to investigate the response rate of carboplatin and paclitaxel in patients with vulvar carcinoma
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 13, 2019

Study Start

January 16, 2020

Primary Completion

January 1, 2024

Study Completion (Estimated)

January 1, 2029

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

NL(1)