Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)

NCT04192253 | Recruiting Phase 2

• 1 other identifier: M19VLC
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced, Squamous Cell Carcinoma of the Vulva

Outcome Measures

Primary Outcomes (1)

• tumour size change by neoadjuvant chemotherapy

  tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1

  18 weeks

Secondary Outcomes (3)

• avoidance of exenterative or invalidating surgery

  21 weeks

• Chemotherapy related morbidity

  21 weeks

• overall survival

  5 years after treatment

Study Arms (1)

neo-adjuvant Paclitaxel and Carboplatin

EXPERIMENTAL

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

Drug: Paclitaxel and Carboplatin

Interventions

Paclitaxel and Carboplatin DRUG

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

neo-adjuvant Paclitaxel and Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: vulva carcinoma
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

NKI-AVL

Amsterdam, 1066CX, Netherlands

RECRUITING

MeSH Terms

Interventions

Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Frederic Amant, MD, PHD

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic Amant, MD, PhD

CONTACT

0031205129111; f.amant@nki.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a prospective, phase ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: December 10, 2019
• Study Start: January 14, 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)