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Trial record 1 of 1 for:    NCT05076942
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Groningen International Study on Sentinel Nodes in Vulvar Cancer-III (GROINSS-VIII)

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ClinicalTrials.gov Identifier: NCT05076942
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Maaike Oonk, University Medical Center Groningen

Study Description
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Brief Summary:
Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

Condition or disease Intervention/treatment Phase
Vulvar Cancer Sentinel Lymph Node Lymph Node Metastases Radiation: Radiotherapy combined with cisplatin Drug: Cisplatin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 157 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: phase II treatment trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2028
Estimated Study Completion Date : January 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer
Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
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
 Radiation: Radiotherapy combined with cisplatin
Inguinofemoral radiotherapy combined with weekly cisplatin
Other Name: chemotherapy

Drug: Cisplatin
Inguinofemoral radiotherapy combined with weekly cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. Groin recurrence rate [ Time Frame: Within first 2 years after primary treatment ]
    Groin recurrence in the groin with SN metastasis treated with chemoradiation


Secondary Outcome Measures :
  1. Treatment related morbidity [ Time Frame: First two years after primary treatment ]
    Short and longterm morbidty

  2. Quality of life as assessed using EORTC-QLQc30 [ Time Frame: First two year after primary treatment ]
    Quality of life

  3. Quality of life-vulvar cancer specific, as assessed using VU34 [ Time Frame: First two year after primary treatment ]
    Quality of life-vulvar cancer specific


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076942


Contacts
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Contact: Maaike H Oonk, MD PhD +31-50-3613000 m.h.m.oonk@umcg.nl
Contact: Liza Lahaye eventinbox@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9712RB
Contact: Maaike H Oonk, MD PhD    +31-50-3613000    m.h.m.oonk@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen
Dutch Cancer Society
More Information
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Responsible Party: Maaike Oonk, Principle Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT05076942    
Other Study ID Numbers: 2016-00601
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vulvar Neoplasms
Lymphatic Metastasis
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Vulvar Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Cisplatin
Antineoplastic Agents