Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
132
Countries
4
Sites
26
Vulvar cancer
To investigate the safety of replacing inguinofemoral lymphadenectomy (with or without adjuvant (chemo)radiation) by chemoradiation alone in early-stage vulvar cancer patients with a macrometastasis (> 2mm) in the sentinel lymph node
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 19 Nov 2020 → ongoing
- Decision date (initial)
- 2025-04-14
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508722-99-00
- EudraCT number
- 2016-003973-16
- ClinicalTrials.gov
- NCT05076942
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To investigate the safety of replacing inguinofemoral lymphadenectomy (with or without adjuvant (chemo)radiation) by chemoradiation alone in early-stage vulvar cancer patients with a macrometastasis (> 2mm) in the sentinel lymph node
Secondary objectives 1
- Evaluate short- and longterm morbidity associated with this treatment
Conditions and MedDRA coding
Vulvar cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- histological confirmed primary squamous cell carcinoma of the vulva
- Age 18 years or older
- Life expectancy of more than 12 weeks
- unifocal T1 tumor with a diamater < 4cm
- No enlarged or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)
- possibility to obtain informed consent
- metastatic sentinel lymph node: size of metastasis > 2mm and / or extracapsular extension, or more than 1 sentinel node with a metastasis </= 2mm
- patients are able to understand requirements of study and comply with the study and follow-up procedures
- adequate bone marrow, renal and liver function
- performance status of 0, 1, or 2 on the ECOG Scale
Exclusion criteria 9
- inoperable tumors and tumors > 4cm
- multifocal tumors
- tumors with other histology than squamous cell carcinoma
- patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
- no other carcinomas, other than basal cell carcinoma, within the last 5 years
- history of pelvic radiotherapy
- history of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment
- pregnant female or nursing mother
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- Groin recurrences
Secondary endpoints 3
- Treatment related morbidity
- Disease-specific survival
- Patient reported quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Cisplatin Accord Healthcare 1 mg/ml concentraat voor oplossing voor infusie
PRD1951593 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 40 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE415667
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord Healthcare 10 mg/ml concentraat voor oplossing voor infusie
PRD2005398 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 2000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- BE 421811
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Maaike Oonk
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Maaike Oonk
Locations
4 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 37 | 4 |
| France | Ongoing, recruiting | 19 | 9 |
| Netherlands | Ongoing, recruiting | 20 | 9 |
| Sweden | Ongoing, recruiting | 16 | 4 |
| Rest of world
United States, Canada
|
— | 40 | — |
Investigational sites
Algemeen Ziekenhuis Delta
Radiotherapy, Deltalaan 1, 8800, Roeselare
Algemeen Ziekenhuis Groeninge
Radiotherapy, President Kennedylaan 4, 8500, Kortrijk
Az St-Jan Brugge-Oostende A.V.
Radiotherapy, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Gent
Radiotherapy, Corneel Heymanslaan 10, 9000, Gent
Institut Curie
Chirurgie Oncologique, 26 Rue D Ulm, 75005, Paris
Institut Curie
Chirurgie Oncologique, 35 Rue Dailly, 92210, Saint-Cloud
Centre Jean Perrin
Chirurgie, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Oscar Lambret
Gynécologie, 3 Rue Frederic Combemale, 59000, Lille
Centre Leon Berard
Chirurgie, 28 Rue Laennec, 69008, Lyon
Institut Paoli Calmettes
Chirurgie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Oncopole Claudius Regaud
Chirurgie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
Chirurgie, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Mutualiste Montsouris
Mère-Enfant, 42 Boulevard Jourdan, 75014, Paris
Universiteit Maastricht
Obstetrie en Gynaecologie, P Debyelaan 25, 6229 HX, Maastricht
Radboud universitair medisch centrum / RADBOUDUMC
Gynaecologische Oncologie, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Groningen
Gynaecologie en Obstetrie, Hanzeplein 1, 9713 GZ, Groningen
Leids Universitair Medisch Centrum (LUMC)
Gynaecologische Oncologie, Albinusdreef 2, 2333 ZA, Leiden
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Gynaecologische Oncologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC Stichting
Gynaecologische Oncologie, Meibergdreef 9, 1105 AZ, Amsterdam
Catharina Ziekenhuis Stichting
Gynaecologische Oncologie, Michelangelolaan 2, 5623 EJ, Eindhoven
Universiteit Utrecht
Gynaecologische Oncologie, Heidelberglaan 100, 3584 CX, Utrecht
Netherlands Cancer Institute
Gynaecologie, Plesmanlaan 121, 1066 CX, Amsterdam
Region Oestergoetland
Gynekologisk onkologi, Universitetssjukhuset I, 58185, Linkoping
Region Skane Skanes Universitetssjukhus
Kvinnokliniken, Entregatan 7, 222 42, Lund
University Of Gothenburg
Gynekologisk onkologi, P. O. Box 100, 405 30, Gothenburg
Karolinska University Hospital
Gynekologisk onkologi, Norrbacka S3 02, 171 76, Stockholm
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-11-18 | 2025-11-18 | |||
| Netherlands | 2020-11-19 | 2021-01-29 | |||
| Sweden | 2025-11-12 | 2025-11-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508722-99-00 _Redacted | 15 |
| Protocol (for publication) | D4_Questionnaire_QLQ-C30 English GROINSS | 3 |
| Protocol (for publication) | D4_Questionnaire_VU34 English GROINSS | 1 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment arrangements and informedconsent | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_SE_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | D4_BE_Patient Facing Documents_Questionnaire_EORTC QLQ-C30 NL | 1 |
| Subject information and informed consent form (for publication) | D4_BE_Patient Facing Documents_Questionnaire_EORTC QLQVU34 NL | 1 |
| Subject information and informed consent form (for publication) | D4_Patient Facing Documents_Questionnaire_EORTC QLQ-C30 SE | 3 |
| Subject information and informed consent form (for publication) | D4_Patient Facing Documents_Questionnaire_EORTC QLQVU34 SE | 1 |
| Subject information and informed consent form (for publication) | L1 BE SIS and ICF FR v1 1TC | 1.1 TC |
| Subject information and informed consent form (for publication) | L1 BE SIS and ICF NL v1 1TC | 1.1 TC |
| Subject information and informed consent form (for publication) | L1_ Sponsor statement Model SIS and ICF | 1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS and ICF_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_SIS and ICF_NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adult | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC cisplatin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL 2023-508722-99-00 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Netherlands | Acceptable 2024-03-12
|
2024-03-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-08 | Netherlands | Acceptable 2024-10-03
|
2024-10-03 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-11-25 | Acceptable 2024-10-03
|
2025-01-21 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-12-19 | Acceptable 2024-10-03
|
2025-03-14 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-02-10 | 2025-04-14 |