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Vulvar CancerPhase 2GROINSS-VIIINCT05076942

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

A Phase 2 study testing Radiotherapy combined with cisplatin and Cisplatin in people with Vulvar Cancer and Sentinel Lymph Node, run by University Medical Center Groningen at 27 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Radiotherapy combined with cisplatin and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
27 sitesin 2 countries
Study dates
1 Jan 2021to 1 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

27 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Maaike H Oonk, MD PhD contact

+31-50-3613000

m.h.m.oonk@umcg.nl

Liza Lahaye contact

eventinbox@umcg.nl

27 sites in 2 countries

United States21 sites, 21 recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Mario Leitao

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Christa Nagel

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Mario Leitao

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Diandra Ayala-Peacock

    Recruiting

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

    Kathleen Yost

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Mario Leitao

    Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Nicola Spirtos

    Recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Brian Slomovitz

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Mario Leitao

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Mario Leitao

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Mario Leitao

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Laura Holman

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Brent Tierney

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Krishnansu Tewari

    Recruiting

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

    Paul DiSilvestro

    Recruiting

  • Duke Women's Cancer Care Raleigh

    Raleigh, North Carolina, 27607

    Daindra Ayala-Peacock

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    David Starks

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Tashanna Myers

    Recruiting

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

    Adam Walter

    Recruiting

  • Munson Medical Center

    Traverse City, Michigan, 49684

    Kathleen Yost

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Mario Leitao

    Recruiting

Other trials in United States

Netherlands6 sites, 6 recruiting

  • Catharina Hospital Eindhoven

    Eindhoven, 5623EJ

    Dorry Boll

    Recruiting

  • University Medical Center Groningen

    Groningen, 9712RB

    Maaike H Oonk, MD PhD, +31-50-3613000, m.h.m.oonk@umcg.nl

    Recruiting

  • Leiden University Medical Center

    Leiden, 2333ZA

    Mariette van Poelgeest

    Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525GA

    Joanne de Hullua

    Recruiting

  • Erasmus Medical Center

    Rotterdam, 3015GD

    Lena van Doorn

    Recruiting

  • University Medical Center Utrecht

    Utrecht, 3584CX

    Eleonora van Dorst

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Radiotherapy combined with cisplatin, Cisplatin
Medical subject headings
Vulvar Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy combined with cisplatinRadiation

    Also called chemotherapy

    Inguinofemoral radiotherapy combined with weekly cisplatin

  • CisplatinDrug

    Inguinofemoral radiotherapy combined with weekly cisplatin

Study groups in NCT05076942
Study groupRoleWhat they receive
ChemoradiationExperimentalInguinofemoral 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
Receives: Radiation: Radiotherapy combined with cisplatin; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Groin recurrence rate

    Groin recurrence in the groin with SN metastasis treated with chemoradiation

    Measured: Within first 2 years after primary treatment

Secondary outcomes (3)

  1. Treatment related morbidity

    Short and longterm morbidty

    Measured: First two years after primary treatment

  2. Quality of life as assessed using EORTC-QLQc30

    Quality of life

    Measured: First two year after primary treatment

  3. Quality of life-vulvar cancer specific, as assessed using VU34

    Quality of life-vulvar cancer specific

    Measured: First two year after primary treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
phase II treatment trial
Masking
None (open label)
Enrolment
157 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05076942
Sponsor's protocol ID
2016-00601
Other IDs
NRG-GY024, 2016
Acronym
GROINSS-VIII
Status last verified
Jul 2023
First submitted
15 Aug 2021
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 36653060

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy combined with cisplatin and Cisplatin in people with Vulvar Cancer and Sentinel Lymph Node, run by University Medical Center Groningen at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maaike H Oonk, MD PhD (+31-50-3613000, m.h.m.oonk@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Groin recurrence rate (time frame: Within first 2 years after primary treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05076942, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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