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Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)

Primary Purpose

Metastatic Squamous Cell Carcinoma of the Vulva

Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Paclitaxel and Carboplatin
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Squamous Cell Carcinoma of the Vulva

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

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

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

Outcomes

Primary Outcome Measures

tumour size reduction by neo adjuvant chemotherapy
tumour size reduction measured by RECIST 1.1

Secondary Outcome Measures

chemotherapy related morbidity
chemotherapy related morbidity measured by number and grade of adverse events
overall survival
overall survival

Full Information

First Posted
November 11, 2019
Last Updated
October 18, 2022
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04161664
Brief Title
Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy
Acronym
CRAVAT
Official Title
Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 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 neo adjuvant 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 neo adjuvant 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
Metastatic 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 II trial to investigate the response rate of carboplatin and paclitaxel in patients with vulvar carcinoma
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neo adjuvant Paclitaxel and Carboplatin
Arm Type
Experimental
Arm Description
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Intervention Type
Drug
Intervention Name(s)
Paclitaxel and Carboplatin
Intervention Description
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Primary Outcome Measure Information:
Title
tumour size reduction by neo adjuvant chemotherapy
Description
tumour size reduction measured by RECIST 1.1
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
chemotherapy related morbidity
Description
chemotherapy related morbidity measured by number and grade of 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 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 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

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Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

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