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Recruiting NCT05076942

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Phase II Interventional Vulvar Cancer Sentinel Lymph Node Lymph Node Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy combined with cisplatin, Cisplatin.
Who it may be relevant to
Registry conditions: Vulvar Cancer, Sentinel Lymph Node, Lymph Node Metastases. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial

Overview

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

Detailed description

Rationale:

Standard treatment of early stage vulvar cancer is a wide local excision of the primary tumor combined with the sentinel node (SN) procedure for the groins. An inguinofemoral lymphadenectomy (IFL) is only indicated in case of a positive SN. An IFL is associated with major morbidity, e.g. wound healing problems, lymphoceles, lymphedema of the legs and recurrent infections. GROINSS-V II investigated whether radiotherapy would be a safe alternative for IFL in case of SN metastasis. The results for radiotherapy in the group with metastasis ≤ 2mm are promising. This study also showed that for metastasis \> 2mm, only radiotherapy was not efficient. The efficacy of treatment can be increased by adding chemotherapy or giving a higher dose of radiotherapy. GROINSS-V III will investigate this regimen.

Objective:

The primary objective of this study is to investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in early stage vulvar cancer patients with a macrometastasis (\>2mm) and/or extracapsular extension in the SN. The secondary objective is to evaluate the short and long-term morbidity associated with the SN procedure and chemoradiation.

Study design: Phase II treatment trial, with stopping rules for the incidence of groin recurrences.

Study population: early-stage vulvar cancer patients with a metastasis \> 2mm in their SN, or more than one metastasis ≤ 2mm.

Intervention: Participants will be treated with chemoradiation, in a total dose of 56Gy to the involved site, combined with weekly cisplatin 40mg/m2

Main study parameters/endpoints: The primary endpoint is the groin recurrence rate in the first 2 years after primary treatment.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: participants will be treated with chemoradiation during 5 weeks instead of surgical treatment. There is a risk that this treatment will not be as effective as surgical treatment, which may lead to more groin recurrences which are hard to treat. By continuously monitoring the groin recurrence rate the investigators will notice activation of the stopping rule as early as possible.

Interventions

  • Radiation Radiotherapy combined with cisplatin
    Inguinofemoral radiotherapy combined with weekly cisplatin
  • Drug Cisplatin
    Inguinofemoral radiotherapy combined with weekly cisplatin

Primary outcome measures

  • Groin recurrence rate [Time frame: Within first 2 years after primary treatment]
Secondary outcome measures (3)
  • Treatment related morbidity [Time frame: First two years after primary treatment]
  • Quality of life as assessed using EORTC-QLQc30 [Time frame: First two year after primary treatment]
  • Quality of life-vulvar cancer specific, as assessed using VU34 [Time frame: First two year after primary treatment]

Eligibility criteria

Inclusion criteria

  • Histological confirmed primary SCC of the vulva
  • T1 tumor, not encroaching urethra/vagina/anus
  • Depth of invasion > 1mm
  • Tumor diameter < 4cm
  • Unifocal tumor
  • No enlarged (>1.5cm) 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
  • Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm
  • Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
  • Adequate bone marrow, renal and liver function:
  • Absolute neutrophil count ≥ 1.5 x 109 /L
  • Platelet count ≥ 100 x 109 /L
  • Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula
  • Total bilirubin < 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN
  • Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A)
  • Age 18 years or older
  • Life expectancy of ≥ 12 weeks
  • Written informed consent

Exclusion criteria

  • Inoperable tumors and tumors > 4cm
  • Multifocal tumors
  • Tumors with other pathology 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 carcinomas, within 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
  • Desire to become pregnant
  • Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
  • Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6 months before enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 21 centers
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
  • Mount Sinai Medical Center — Miami Beach
  • Baystate Medical Center — Springfield
  • Spectrum Health at Butterworth Campus — Grand Rapids
  • Munson Medical Center — Traverse City
  • Nebraska Methodist Hospital — Omaha
  • Women's Cancer Center of Nevada — Las Vegas
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge
  • … and 13 more centers
Netherlands · 6 centers
  • Catharina Hospital Eindhoven — Eindhoven
  • University Medical Center Groningen — Groningen
  • Leiden University Medical Center — Leiden
  • Radboud University Medical Center — Nijmegen
  • Erasmus Medical Center — Rotterdam
  • University Medical Center Utrecht — Utrecht

Publications

  • Gien LT, Slomovitz B, Van der Zee A, Oonk M. Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024). Int J Gynecol Cancer. 2023 Apr 3;33(4):619-622. doi: 10.1136/ijgc-2022-004122. PMID 36653060

Identifiers

NCT: NCT05076942 · 2016-00601 · NRG-GY024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗