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

Launched by THE NETHERLANDS CANCER INSTITUTE · Jun 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for women with locally advanced vulvar cancer, which is a type of skin cancer that affects the vulva. The trial compares standard treatment, which includes a combination of radiation therapy and chemotherapy, to an experimental treatment that involves chemotherapy followed by surgery. The goal is to see which method is more effective and safer for patients.

To participate in this trial, women must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma of the vulva at a certain stage. They should have tumors that are either large or located in ways that make them hard to treat with surgery alone. Participants can expect to receive either of the two treatment options and will be closely monitored for their health and response to treatment. It's important to note that certain conditions, like having previous pelvic radiation or serious mental health issues, may exclude someone from participating. If you or someone you know is interested, be sure to discuss it with a healthcare provider for more information.

Gender

FEMALE

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