Clinical trial • Phase II • Oncology|Other

CISPLATIN for Vulvar cancer|Squamous cell carcinoma of the vulva

Phase II trial of CISPLATIN for Vulvar cancer|Squamous cell carcinoma of the vulva. None/Not specified-controlled. 92 participants.

Overview

Trial Therapeutic Area
Oncology|Other
Trial Disease
Vulvar cancer|Squamous cell carcinoma of the vulva
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-02-2024
First CTIS Authorization Date
12-03-2024

Trial design

None/Not specified-controlled Phase II trial across 26 sites in Netherlands, France, Sweden and others.

Comparator
None/Not specified
Target Sample Size
92
Trial Duration For Participant
730

Eligibility

Recruits 92 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be adults (Age 18 years or older) and able to provide informed consent (inclusion: possibility to obtain informed consent; patients able to understand requirements of study). Subject information and informed consent forms are provided (documents listed: L1_SIS and ICF_adult and country-specific ICFs in Dutch, French, Swedish, English). No assent process for minors is described..

Pregnancy Exclusion
pregnant female or nursing mother
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be adults (Age 18 years or older) and able to provide informed consent (inclusion: possibility to obtain informed consent; patients able to understand requirements of study). Subject information and informed consent forms are provided (documents listed: L1_SIS and ICF_adult and country-specific ICFs in Dutch, French, Swedish, English). No assent process for minors is described.

Inclusion criteria

  • {"criterion_text":"- histological confirmed primary squamous cell carcinoma of the vulva\n- performance status of 0, 1, or 2 on the ECOG Scale\n- Age 18 years or older\n- Life expectancy of more than 12 weeks\n- unifocal T1 tumor with a diamater < 4cm\n- No enlarged or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)\n- possibility to obtain informed consent\n- metastatic sentinel lymph node: size of metastasis > 2mm and / or extracapsular extension, or more than 1 sentinel node with a metastasis </= 2mm\n- patients are able to understand requirements of study and comply with the study and follow-up procedures\n- adequate bone marrow, renal and liver function"}

Exclusion criteria

  • {"criterion_text":"- inoperable tumors and tumors > 4cm\n- multifocal tumors\n- tumors with other histology than squamous cell carcinoma\n- patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology\n- no other carcinomas, other than basal cell carcinoma, within the last 5 years\n- history of pelvic radiotherapy\n- history of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment\n- pregnant female or nursing mother\n- unstable angina, myocardial infarction, cerebrovascular accident, > class II congestive heart failure according to the NY Heart Association Classification of Congestive Heart Failure within 6 months before enrollment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Groin recurrences","definition_or_measurement_approach":"Number of groin recurrences in the first 2 years after treatment"}

Secondary endpoints

  • {"endpoint_text":"- Treatment related morbidity\n- Disease-specific survival\n- Patient reported quality of life","definition_or_measurement_approach":"Treatment related morbidity: as defined in protocol (treatment-related adverse events and morbidity). Disease-specific survival: disease-specific survival as an outcome (time to death from disease). Patient reported quality of life: measured by patient-reported instruments (e.g. EORTC QLQ-C30 and QLQ-VU34 questionnaires listed in documents)."}

Recruitment

Planned Sample Size
92
Recruitment Window Months
116
Consent Approach
Informed consent is required from participants (inclusion criterion: possibility to obtain informed consent; participants must be able to understand study requirements). Subject information and informed consent forms are provided (documents include L1_SIS and ICF_adult and country-specific ICFs). Language-specific ICFs/documents are available (documents list English, Dutch, French, Swedish versions for patient-facing documents and ICFs). No assent process for minors is described.

Geography

Total Number Of Sites
26
Total Number Of Participants
92

Netherlands

Earliest CTIS Part Ii Submission Date
26-02-2024
Latest Decision Or Authorization Date
12-03-2024
Processing Time Days
15
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Netherlands Cancer Institute
Department Name
Gynaecologie
Principal Investigator Name
Henry Zijlmans
Principal Investigator Email
h.zijlmans@nki.nl
Contact Person Name
Henry Zijlmans
Contact Person Email
h.zijlmans@nki.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Gynaecologische Oncologie
Principal Investigator Name
Mariette Van Poelgeest
Principal Investigator Email
m.i.e.van_poelgeest@lumc.nl
Contact Person Name
Mariette Van Poelgeest
Contact Person Email
m.i.e.van_poelgeest@lumc.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Gynaecologische Oncologie
Principal Investigator Name
Dorry Boll
Principal Investigator Email
dorry.boll@catharinaziekenhuis.nl
Contact Person Name
Dorry Boll
Site Name
Universiteit Maastricht
Department Name
Obstetrie en Gynaecologie
Principal Investigator Name
Brigitte Slangen
Principal Investigator Email
brigitte.slangen@mumc.nl
Contact Person Name
Brigitte Slangen
Contact Person Email
brigitte.slangen@mumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Gynaecologie en Obstetrie
Principal Investigator Name
Maaike Oonk
Principal Investigator Email
m.h.m.oonk@umcg.nl
Contact Person Name
Maaike Oonk
Contact Person Email
m.h.m.oonk@umcg.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Gynaecologische Oncologie
Principal Investigator Name
Joanne Dehullu
Principal Investigator Email
Joanne.deHullu@radboudumc.nl
Contact Person Name
Joanne Dehullu
Contact Person Email
Joanne.deHullu@radboudumc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Gynaecologische Oncologie
Principal Investigator Name
Ming Tjiong
Principal Investigator Email
m.tjiong@amsterdamumc.nl
Contact Person Name
Ming Tjiong
Contact Person Email
m.tjiong@amsterdamumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Gynaecologische Oncologie
Principal Investigator Name
Lena Van Doorn
Principal Investigator Email
h.vandoorn@erasmusmc.nl
Contact Person Name
Lena Van Doorn
Contact Person Email
h.vandoorn@erasmusmc.nl
Site Name
Universiteit Utrecht
Department Name
Gynaecologische Oncologie
Principal Investigator Name
Eleonora Van Dorst
Principal Investigator Email
e.b.l.vandorst-2@umcutrecht.nl
Contact Person Name
Eleonora Van Dorst
Contact Person Email
e.b.l.vandorst-2@umcutrecht.nl

France

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
21-01-2025
Processing Time Days
77
Number Of Sites
9
Number Of Participants
19

Sites

Site Name
Institut Mutualiste Montsouris
Department Name
Mère-Enfant
Principal Investigator Name
Christine Louis-Sylvestre
Principal Investigator Email
Christine.louis-sylvestre@imm.fr
Contact Person Name
Christine Louis-Sylvestre
Site Name
Institut Gustave Roussy
Department Name
Chirurgie
Principal Investigator Name
Sébastien Gouy
Principal Investigator Email
Sebastien.GOUY@gustaveroussy.fr
Contact Person Name
Sébastien Gouy
Site Name
Institut Curie
Department Name
Chirurgie Oncologique
Principal Investigator Name
Virginie Fourchotte
Principal Investigator Email
Virginie.fourchotte@curie.fr
Contact Person Name
Virginie Fourchotte
Contact Person Email
Virginie.fourchotte@curie.fr
Site Name
Oncopole Claudius Regaud
Department Name
Chirurgie
Principal Investigator Name
Alejandra Martinez
Principal Investigator Email
Martinez.alejandra@iuct-oncopole.fr
Contact Person Name
Alejandra Martinez
Site Name
Centre Jean Perrin
Department Name
Chirurgie
Principal Investigator Name
Caroline Cornou
Principal Investigator Email
Caroline.cornou@clermont.unicancer.fr
Contact Person Name
Caroline Cornou
Site Name
Institut Curie (Saint-Cloud)
Department Name
Chirurgie Oncologique
Principal Investigator Name
Eugénie Guillot
Principal Investigator Email
eugenie.guillot@curie.fr
Contact Person Name
Eugénie Guillot
Contact Person Email
eugenie.guillot@curie.fr
Site Name
Institut Paoli Calmettes
Department Name
Chirurgie
Principal Investigator Name
Camille Jauffret
Principal Investigator Email
jauffretc@ipc.unicancer.fr
Contact Person Name
Camille Jauffret
Contact Person Email
jauffretc@ipc.unicancer.fr
Site Name
Centre Oscar Lambret
Department Name
Gynécologie
Principal Investigator Name
Fabrice Narducci
Principal Investigator Email
f-narducci@o-lambret.fr
Contact Person Name
Fabrice Narducci
Contact Person Email
f-narducci@o-lambret.fr
Site Name
Centre Leon Berard
Department Name
Chirurgie
Principal Investigator Name
Mellie Heinemann
Principal Investigator Email
Mellie.heinemann@lyon.unicancer.fr
Contact Person Name
Mellie Heinemann

Sweden

Earliest CTIS Part Ii Submission Date
19-02-2025
Latest Decision Or Authorization Date
14-03-2025
Processing Time Days
23
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Karolinska University Hospital
Department Name
Gynekologisk onkologi
Principal Investigator Name
Christina Hellman
Principal Investigator Email
christina.hellman@regionstockholm.se
Contact Person Name
Christina Hellman
Site Name
University Of Gothenburg
Department Name
Gynekologisk onkologi
Principal Investigator Name
Karin Bergmark
Principal Investigator Email
karin.bergmark@vgregion.se
Contact Person Name
Karin Bergmark
Contact Person Email
karin.bergmark@vgregion.se
Site Name
Region Oestergoetland
Department Name
Gynekologisk onkologi
Principal Investigator Name
Oscar Derke
Principal Investigator Email
Oscar.derke@regionstergotland.se
Contact Person Name
Oscar Derke
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Kvinnokliniken
Principal Investigator Name
Zuzana Kolkova
Principal Investigator Email
zuzana.kolkova@skane.se
Contact Person Name
Zuzana Kolkova
Contact Person Email
zuzana.kolkova@skane.se

Belgium

Earliest CTIS Part Ii Submission Date
31-03-2025
Latest Decision Or Authorization Date
14-04-2025
Processing Time Days
14
Number Of Sites
4
Number Of Participants
37

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Radiotherapy
Principal Investigator Name
Karin Stellamans
Principal Investigator Email
Karin.stellamans@azgroeninge.be
Contact Person Name
Karin Stellamans
Site Name
Universitair Ziekenhuis Gent
Department Name
Radiotherapy
Principal Investigator Name
Katrien Vandecasteele
Principal Investigator Email
Katrien.Vandecasteele@uzgent.be
Contact Person Name
Katrien Vandecasteele
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Radiotherapy
Principal Investigator Name
Sarah Roels
Principal Investigator Email
Sarah.roels@azsintjan.be
Contact Person Name
Sarah Roels
Contact Person Email
Sarah.roels@azsintjan.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Radiotherapy
Principal Investigator Name
Caroline Sweldens
Principal Investigator Email
Caroline.sweldens@azdelta.be
Contact Person Name
Caroline Sweldens
Contact Person Email
Caroline.sweldens@azdelta.be

Sponsor

Primary sponsor

Full Name
Universitair Medisch Centrum Groningen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Cisplatin Accord Healthcare 1 mg/ml concentraat voor oplossing voor infusie
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
maxDailyDoseAmount 40 mg/m2; maxTotalDoseAmount 200 mg/m2
Investigational Product Name
Carboplatin Accord Healthcare 10 mg/ml concentraat voor oplossing voor infusie
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
maxDailyDoseAmount 400 mg/m2; maxTotalDoseAmount 2000 mg/m2
Combination Treatment
Yes

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