Back to resultsTreatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize) (VULCANize)
Primary Purpose
Locally Advanced, Squamous Cell Carcinoma of the Vulva
Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Paclitaxel and Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced, Squamous Cell Carcinoma of the Vulva
Eligibility Criteria
Inclusion Criteria:
- 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
- Adequate renal function
- Negative pregnancy test for woman of childbearing potential
- measurable disease by physical examination
- TNM stage T2, any N, MO
Exclusion Criteria:
- 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
Sites / Locations
- NKI-AVLRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neo-adjuvant Paclitaxel and Carboplatin
Arm Description
Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Outcomes
Primary Outcome Measures
tumour size change by neoadjuvant chemotherapy
tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1
Secondary Outcome Measures
avoidance of exenterative or invalidating surgery
number of patients were surgery can be reduced after the neo-adjuvant chemotherapy
Chemotherapy related morbidity
Chemotherapy related morbidity measured by reported adverse events
overall survival
overall survival
Full Information
NCT ID
NCT04192253
First Posted
November 11, 2019
Last Updated
October 18, 2022
Sponsor
The Netherlands Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04192253
Brief Title
Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Acronym
VULCANize
Official Title
Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced, Squamous Cell Carcinoma of the Vulva
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neo-adjuvant Paclitaxel and Carboplatin
Arm Type
Experimental
Arm Description
Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and Carboplatin
Intervention Description
Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Primary Outcome Measure Information:
Title
tumour size change by neoadjuvant chemotherapy
Description
tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
avoidance of exenterative or invalidating surgery
Description
number of patients were surgery can be reduced after the neo-adjuvant chemotherapy
Time Frame
21 weeks
Title
Chemotherapy related morbidity
Description
Chemotherapy related morbidity measured by reported adverse events
Time Frame
21 weeks
Title
overall survival
Description
overall survival
Time Frame
5 years after treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
vulva carcinoma
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Adequate renal function
Negative pregnancy test for woman of childbearing potential
measurable disease by physical examination
TNM stage T2, any N, MO
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic Amant, MD, PhD
Phone
0031205129111
Email
f.amant@nki.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Amant, MD, PHD
Organizational Affiliation
NKI-AvL
Official's Role
Principal Investigator
Facility Information:
Facility Name
NKI-AVL
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NKI-AVL Zijlmans, MD, PhD
Phone
0031205129111
Email
h.zijlmans@nki.nl
First Name & Middle Initial & Last Name & Degree
Henry Zijlmans, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
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