Actively Recruiting
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
Led by The Netherlands Cancer Institute · Updated on 2024-04-15
98
Participants Needed
2
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman aged 18 years or older
- Signed and written informed consent
- Histologically confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib to IVa, T1b or higher, any N, M0
- Local tumor requiring primary chemoradiation or extensive surgery due to size or location, including T1b or larger tumors with irresectable groin metastases or involvement of urethra or anal sphincter
- World Health Organization performance status of 0-2
- Adequate blood function with platelet count >100x10E9/L, leukocyte count >3x10E9/L or neutrophil count >1.5x10E9/L, and hemoglobin >6.0 mmol/L
- Adequate liver function with total bilirubin ≤1.5 times upper limit of normal and ASAT and ALAT ≤2.5 times upper limit of normal
- Adequate kidney function with estimated creatinine clearance ≥50 mL/min
- Beta HCG level 14 mIU/mL or below for women of childbearing potential
- Use of highly effective contraception if risk of conception exists
You will not qualify if you...
- Presence of highly suspicious or positive metastases to the pelvic lymph nodes
- Patients eligible for radical local excision without involvement of other organs
- Any psychiatric condition preventing understanding or giving informed consent
- Prior radiotherapy to pelvis or groin limiting full dose chemoradiation
- Existing neuropathy that would interfere with chemotherapy intake
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NKI-AVL
Amsterdam, Netherlands
Actively Recruiting
2
LUMC
Leiden, Netherlands
Actively Recruiting
Research Team
F
Frederic Amant, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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