CTIS2022-502685-25-00
Recruiting
Phase 1
Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)
Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis0 sites98 target enrollmentMay 10, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The trial population will consist of patients with LAVC who require primary chemoradiation orextensive surgery damaging pelvic organs or exenterative surgery.
- Sponsor
- Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
- Enrollment
- 98
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Woman \= 18 years, 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, Highly effective contraception for patients if the risk of conception exists, 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. Or this can imply: 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 neutrophil count \>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 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)
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, Patients eligible for radical local excision without involvement of other organs
Outcomes
Primary Outcomes
Not specified
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