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

• Status: Not yet recruiting
• Trial end date: 2029-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Woman ≥ 18 years

• Signed and written informed consent.

• Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage II - IVa, T2 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;

• T2 or larger tumour with (irresectable) groin metastases

• T2 or larger tumour with 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

• 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