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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05076942
Other study ID # 2016-00601
Secondary ID NRG-GY024
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2029

Study information

Verified date July 2023
Source University Medical Center Groningen
Contact Maaike H Oonk, MD PhD
Phone +31-50-3613000
Email m.h.m.oonk@umcg.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 157
Est. completion date January 1, 2029
Est. primary completion date January 1, 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Netherlands Catharina Hospital Eindhoven Eindhoven
Netherlands University Medical Center Groningen Groningen
Netherlands Leiden University Medical Center Leiden
Netherlands Radboud University Medical Center Nijmegen
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Duke University Medical Center Durham North Carolina
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Memorial Sloan Kettering Westchester Harrison New York
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Mount Sinai Medical Center Miami Beach Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Women and Infants Hospital Providence Rhode Island
United States Duke Women's Cancer Care Raleigh Raleigh North Carolina
United States Avera Cancer Institute Sioux Falls South Dakota
United States Baystate Medical Center Springfield Massachusetts
United States ProMedica Flower Hospital Sylvania Ohio
United States Munson Medical Center Traverse City Michigan
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (3)

Lead Sponsor Collaborator
University Medical Center Groningen Dutch Cancer Society, NRG Oncology

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Groin recurrence rate Groin recurrence in the groin with SN metastasis treated with chemoradiation Within first 2 years after primary treatment
Secondary Treatment related morbidity Short and longterm morbidty First two years after primary treatment
Secondary Quality of life as assessed using EORTC-QLQc30 Quality of life First two year after primary treatment
Secondary Quality of life-vulvar cancer specific, as assessed using VU34 Quality of life-vulvar cancer specific First two year after primary treatment
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