Comparing two treatment strategies for advanced vulvar cancer

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

This study is testing two different treatment plans for advanced vulvar cancer to see which one works better for patients needing intensive care.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The Netherlands Cancer Institute (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Amsterdam and 1 other locations)
• Trial ID: NCT05905315 on ClinicalTrials.gov

What this trial studies

This phase 2 randomized controlled trial aims to evaluate the efficacy and safety of two treatment approaches for locally advanced vulvar carcinoma. The standard treatment involves primary chemoradiation, while the experimental treatment consists of neoadjuvant chemotherapy followed by surgery. A total of 98 patients will be enrolled from eight national medical centers, and the study will compare the outcomes of these two strategies. The trial focuses on patients with specific tumor characteristics that necessitate intensive treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with histologically-confirmed locally advanced squamous cell carcinoma of the vulva.

Not a fit: Patients with early-stage vulvar cancer or those who do not meet the specific tumor criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with locally advanced vulvar carcinoma.

How similar studies have performed: Other studies have explored treatment strategies for vulvar cancer, but this specific comparison of chemoradiation versus neoadjuvant chemotherapy is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Woman ≥ 18 years
* Signed and written informed consent.
* Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib - IVa, T1b or higher, any N, M0.
* Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative surgery). This can imply;

  * T1b or larger tumour with (irresectable) groin metastases
  * T1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter
* World Health Organization performance status of 0-2
* Adequate haematological function defined by platelet count \>100x10E9/L, absolute leukocyte \>3X10E9/L or neutrophil count (ANC) \>1.5x10E9/L, and hemoglobin \>6.0 mmol/L
* Adequate hepatic function defined by a total bilirubin level ≤1.5x the upper limit of normal (ULN) range and ASAT and ALAT levels ≤2.5x ULN for all subjects
* Adequate renal function defined by an estimated creatinine clearance ≥50mL/min according to the Cockroft-Gault formula (or local institutional standard method)
* Beta HCG level of 14 mIU/mL or below for women of childbearing potential
* Highly effective contraception for patients if the risk of conception exists

Exclusion Criteria:

* Patients with highly suspicious or positive metastases to the pelvic lymph nodes

  \* Patients eligible for radical local excision without involvement of other organs
* Any psychiatric condition that would prohibit the understanding or rendering of informed consent
* Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol
* Existing neuropathy which will hinder the intake of chemotherapy

Where this trial is running

Amsterdam and 1 other locations

• NKI-AVL — Amsterdam, Netherlands (RECRUITING)
• LUMC — Leiden, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Frederic Amant, Prof. — NKI-AvL
• Study coordinator: Frederic Amant, Prof.

Conditions: Locally Advanced Vulvar Carcinoma, Squamous Cell Carcinoma of the Vulva