You are here

  • Home
  • Online First
  • Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)

Article Text

Article menu
Download PDFPDF
Clinical trial
Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)
  1. Frédéric Amant1,2,
  2. Anne Fleur van Velzen2,3,
  3. An Reyners4,
  4. Henry Zijlmans2,
  5. Eva E Schaake5 and
  6. Linda Nooij3
    1. 1Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University Hospitals Leuven, Katholieke Universiteit Leuven, Leuven, Belgium
    2. 2Gynecology, Netherlands Cancer Institute, Amsterdam, Netherlands
    3. 3Gynecology, Leiden University Medical Centre, Leiden, Netherlands
    4. 4Medical Oncology, University Medical Center Groningen, Groningen, Netherlands
    5. 5Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands
    1. Correspondence to Professor Frédéric Amant, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University Hospitals Leuven, Katholieke Universiteit Leuven, Herestraat 49, 3000, Leuven, Belgium; frederic.amant{at}uzleuven.be

    Abstract

    Background Current treatment options for patients with locally advanced vulvar cancer are limited and associated with high morbidity. Therefore, it is important to develop new and safe treatment strategies for this vulnerable patient group.

    Primary Objective To compare the efficacy and safety of neoadjuvant chemotherapy followed by surgery with definitive chemoradiation in patients with locally advanced vulvar cancer.

    Study Hypothesis Neoadjuvant chemotherapy followed by surgery is oncologically safe, potentially more effective than primary chemoradiation in establishing long lasting locoregional control, and associated with an improved quality of life.

    Trial Design This study is a multicenter, prospective, phase II randomized controlled trial. Patients will be randomized 1:1 to the standard treatment arm (primary chemoradiation, consisting of a tumor dose of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for 6 weeks) or the experimental treatment arm (neoadjuvant chemotherapy, consisting of carboplatin and paclitaxel in a 3 weekly scheme, followed by surgery).

    Major Inclusion/Exclusion Criteria Eligible patients must have a histologically confirmed primary or recurrent locally advanced squamous cell carcinoma of the vulva (International Federation of Gynecology and Obstetrics (FIGO) stages Ib–Iva; Lesions larger than 2 cm in size or stromal invasion larger than 1 mm (T1b or higher), any status of lymph node involvement (any N), no distant metastasis including pelvic lymph nodes (M0)) with the size or localization of the tumor requiring treatment through primary chemoradiation or extensive surgery. Patients with documented metastases of the pelvic lymph nodes will be excluded from participation in this study.

    Primary Endpoint Locoregional control at 24 months.

    Sample Size 98 patients will be included in the study.

    Estimated Dates for Completing Accrual and Presenting Results Expected complete accrual in 2028 with presentation of results by 2030.

    Trial Registration ClinicalTrials.gov NCT05905315

    • Vulvar and Vaginal Cancer
    • Pathology
    • Radiation
    • Surgery

    Data availability statement

    There are no data in this work.

    https://doi.org/10.1136/ijgc-2024-005493

    Statistics from Altmetric.com

      Request Permissions

      If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

      Data availability statement

      There are no data in this work.

      View Full Text

      Footnotes

      • EES and LN contributed equally.

      • Contributors All authors have provided substantial contribution and are in agreement with all aspects of the final manuscript. FA: guarantor, conceptualization, methodology, review, and supervision. AFvV: writing original draft. AR: conceptualization, methodology, and review. HZ: conceptualization, methodology, and review. EES: conceptualization, methodology, review, and supervision. LN: conceptualization, methodology, review, and supervision.

      • Funding The study is funded by the Koningin Wilhelmina Fonds (KWF).

      • Competing interests None declared.

      • Provenance and peer review Not commissioned; internally peer reviewed.