Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Part of paid clinical trials in Orange, California.

Sponsor
University Medical Center Groningen
Study ID
NCT05076942
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lymph Node Metastases
  • Sentinel Lymph Node
  • Vulvar Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy combined with cisplatin — RADIATION
    Inguinofemoral radiotherapy combined with weekly cisplatin
  • Cisplatin — DRUG
    Inguinofemoral radiotherapy combined with weekly cisplatin

Study Details

Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

Key Dates

Start date
Jan 1, 2021
Status verified
Jul 2023
Primary completion
Jan 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
157 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemoradiation
    Inguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg/m2 intravenously on days 1, 8, 15, 22 and 29

Primary Outcome Measure

Groin recurrence rate [ Time Frame: Within first 2 years after primary treatment ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Krishnansu Tewari (PRINCIPAL_INVESTIGATOR)
Mount Sinai Medical CenterMiami BeachFlorida33140
Brian Slomovitz (PRINCIPAL_INVESTIGATOR)
Baystate Medical CenterSpringfieldMassachusetts01199
Tashanna Myers (PRINCIPAL_INVESTIGATOR)
Spectrum Health at Butterworth CampusGrand RapidsMichigan49503
Kathleen Yost (PRINCIPAL_INVESTIGATOR)
Munson Medical CenterTraverse CityMichigan49684
Kathleen Yost (PRINCIPAL_INVESTIGATOR)
Nebraska Methodist HospitalOmahaNebraska68114
Brent Tierney (PRINCIPAL_INVESTIGATOR)
Women's Cancer Center of NevadaLas VegasNevada89106
Nicola Spirtos (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920
Mario Leitao (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748
Mario Leitao (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering BergenMontvaleNew Jersey07645
Mario Leitao (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering CommackCommackNew York11725
Mario Leitao (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Mario Leitao (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Mario Leitao (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering NassauUniondaleNew York11553
Mario Leitao (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Diandra Ayala-Peacock (PRINCIPAL_INVESTIGATOR)
Duke Women's Cancer Care RaleighRaleighNorth Carolina27607
Daindra Ayala-Peacock (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Christa Nagel (PRINCIPAL_INVESTIGATOR)
ProMedica Flower HospitalSylvaniaOhio43560
Adam Walter (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Laura Holman (PRINCIPAL_INVESTIGATOR)
Women and Infants HospitalProvidenceRhode Island02905
Paul DiSilvestro (PRINCIPAL_INVESTIGATOR)
Avera Cancer InstituteSioux FallsSouth Dakota57105
David Starks (PRINCIPAL_INVESTIGATOR)

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UC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAMount Sinai Medical Center· Miami Beach, FLBaystate Medical Center· Springfield, MASpectrum Health at Butterworth Campus· Grand Rapids, MIMunson Medical Center· Traverse City, MINebraska Methodist Hospital· Omaha, NE

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