Comparing two treatment strategies for advanced vulvar cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nki-Avl
  Amsterdam, Netherlands Recruiting
• Lumc
  Leiden, Netherlands Recruiting

Study contacts

• Principal investigator: Frederic Amant, Prof. — The Netherlands Cancer Institute
• Study coordinator: Frederic Amant, Prof.
• Email: f.amant@nki.nl
• Phone: 0031205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.