RecruitingPhase 2NCT05905315

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma


Sponsor

The Netherlands Cancer Institute

Enrollment

98 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment strategies for locally advanced vulvar cancer (cancer of the external female genitalia) where the tumor is near or involves sensitive structures. It compares definitive chemoradiation (radiation plus chemotherapy without surgery) versus chemotherapy first followed by surgery. **You may be eligible if...** - You are a woman aged 18 or older - You have confirmed squamous cell carcinoma of the vulva at a locally advanced stage (FIGO stage Ib or higher) - Your tumor is near or involves the urethra or anal sphincter, or you have groin lymph node spread that would require extensive surgery - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to the pelvic lymph nodes - Your tumor could be removed with a simple local excision without involving other organs - You have had prior radiation to the pelvis or groin that would prevent full-dose treatment - You have pre-existing nerve damage that prevents chemotherapy use - You have a psychiatric condition that prevents giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPaclitaxel and Carboplatin

Paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme.

COMBINATION_PRODUCTChemoradiation

According to standard treatment.


Locations(2)

NKI-AVL

Amsterdam, Netherlands

LUMC

Leiden, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05905315