Clinical trial NCT05905315: Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
Official title: Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Vulvar Carcinoma
Squamous Cell Carcinoma of the Vulva
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Loco-regional control after 24 months per completed treatment including salvage treatment
timeFrame: 24 months after completed treatment
Secondary outcomes:
measure: Disease-related treatment failure
timeFrame: 24 months after completed treatment
measure: Disease free survival
timeFrame: 24 months after completed treatment
measure: Patterns of recurrence of disease
timeFrame: 24 months after completed treatment
measure: Overall survival
timeFrame: 24 months after completed treatment
measure: Treatment related death
timeFrame: 24 months after completed treatment
measure: Prevention of trimodal treatment
timeFrame: 24 months after completed treatment
measure: Functional organ preservation
timeFrame: 24 months after completed treatment
measure: Short term and long term complications
timeFrame: 24 months after completed treatment
Other outcomes:
Locations:
city: AMsterdam
country: Netherlands
facility: NKI-AVL
city: Leiden
country: Netherlands
facility: LUMC
Study officials:
affiliation: NKI-AvL
name: Frederic Amant, Prof.
role: PRINCIPAL_INVESTIGATOR
References: