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

October 18, 2022 updated by: The Netherlands Cancer Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Recruiting
        • NKI-AVL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neo adjuvant Paclitaxel and Carboplatin
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Drug: Paclitaxel and Carboplatin
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumour size reduction by neo adjuvant chemotherapy
Time Frame: 18 weeks
tumour size reduction measured by RECIST 1.1
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chemotherapy related morbidity
Time Frame: 21 weeks
chemotherapy related morbidity measured by number and grade of adverse events
21 weeks
overall survival
Time Frame: 5 years after treatment
overall survival
5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2020

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2029

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19CVT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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