Groningen International Study on Sentinel Nodes in Vulvar Cancer-III (GROINSS-VIII)

July 27, 2023 updated by: Maaike Oonk, University Medical Center Groningen

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

157

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Eindhoven, Netherlands, 5623EJ
        • Recruiting
        • Catharina Hospital Eindhoven
        • Principal Investigator:
          • Dorry Boll
      • Groningen, Netherlands, 9712RB
        • Recruiting
        • University Medical Center Groningen
        • Contact:
      • Leiden, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center
        • Principal Investigator:
          • Mariette van Poelgeest
      • Nijmegen, Netherlands, 6525GA
        • Recruiting
        • Radboud University Medical Center
        • Principal Investigator:
          • Joanne de Hullua
      • Rotterdam, Netherlands, 3015GD
        • Recruiting
        • Erasmus Medical Center
        • Principal Investigator:
          • Lena van Doorn
      • Utrecht, Netherlands, 3584CX
        • Recruiting
        • University Medical Center Utrecht
        • Principal Investigator:
          • Eleonora van Dorst
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Principal Investigator:
          • Krishnansu Tewari
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center
        • Principal Investigator:
          • Brian Slomovitz
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Medical Center
        • Principal Investigator:
          • Tashanna Myers
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Principal Investigator:
          • Kathleen Yost
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Principal Investigator:
          • Kathleen Yost
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Principal Investigator:
          • Brent Tierney
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Women's Cancer Center of Nevada
        • Principal Investigator:
          • Nicola Spirtos
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Principal Investigator:
          • Mario Leitao
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Principal Investigator:
          • Mario Leitao
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Principal Investigator:
          • Mario Leitao
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Principal Investigator:
          • Mario Leitao
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Principal Investigator:
          • Mario Leitao
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Mario Leitao
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Principal Investigator:
          • Mario Leitao
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Diandra Ayala-Peacock
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Duke Women's Cancer Care Raleigh
        • Principal Investigator:
          • Daindra Ayala-Peacock
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Christa Nagel
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Principal Investigator:
          • Adam Walter
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Laura Holman
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital
        • Principal Investigator:
          • Paul DiSilvestro
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Principal Investigator:
          • David Starks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • chemotherapy
Drug: Cisplatin
Inguinofemoral radiotherapy combined with weekly cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Groin recurrence rate
Time Frame: Within first 2 years after primary treatment
Groin recurrence in the groin with SN metastasis treated with chemoradiation
Within first 2 years after primary treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related morbidity
Time Frame: First two years after primary treatment
Short and longterm morbidty
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
First two year after primary treatment
Quality of life-vulvar cancer specific, as assessed using VU34
Time Frame: First two year after primary treatment
Quality of life-vulvar cancer specific
First two year after primary treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

NRG Oncology
Dutch Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

August 15, 2021

First Submitted That Met QC Criteria

October 1, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00601
  • NRG-GY024 (Other Identifier: NRG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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