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

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: Metastatic Squamous Cell Carcinoma of the Vulva
• Intervention / Treatment: Drug: Paclitaxel and Carboplatin

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	tumour size reduction measured by RECIST 1.1	18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Study record dates

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: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Vulvar Diseases; Carcinoma; Vulvar Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• 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