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Trial Title:
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
NCT ID:
NCT05905315
Condition:
Locally Advanced Vulvar Carcinoma
Squamous Cell Carcinoma of the Vulva
Conditions: Official terms:
Carcinoma
Vulvar Neoplasms
Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel and Carboplatin
Description:
Paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be
administered in a 3-weekly scheme.
Arm group label:
NACT (3-weekly carboplatin and paclitaxel) followed by surgery
Intervention type:
Combination Product
Intervention name:
Chemoradiation
Description:
According to standard treatment.
Arm group label:
Primary chemoradiation
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Vulva carcinoma
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NKI-AVL
Address:
City:
AMsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
F. Amant
Facility:
Name:
LUMC
Address:
City:
Leiden
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
L. Nooij
Start date:
January 1, 2024
Completion date:
September 1, 2029
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05905315
