An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Testing the Treatment of Radiation and Cisplatin Chemotherapy for Patients with Disease which Has Spread and Been Detected in the Sentinel Nodes in Surgically Resected Vulvar Cancer, (GROINSS-V) III Trial
Trial Status: active
This phase II trial studies the effect of radiation and cisplatin in treating patients with vulvar cancer that has spread to the sentinel lymph nodes, instead of proceeding with extensive groin node dissection followed by radiation. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation and cisplatin may shrink cancer and also be a safer alternative to an extensive groin dissection followed by radiation in patients with vulvar cancer that has spread to the sentinel nodes.
Inclusion Criteria
Histological confirmed primary squamous cell carcinoma (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 (computed tomography [CT]/magnetic resonance imaging [MRI]/ultrasound)
Possibility to obtain informed consent
Metastatic sentinel lymph node; size of metastasis > 2mm and / or extracapsular extension
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
Absolute neutrophil count >= 1.5 x 10^9 /L
Platelet count >= 100 x 10^9 /L
Creatinine clearance >= 40 ml/min measured by the Cockroft-Gault formula
Total bilirubin < 1.25 x upper limit of normal (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)
Age 18 years or older
Life expectancy of >= 12 weeks
Written informed consent
CANADIAN PATIENTS: Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a women over age 45 in the absence of other biological or physiological causes
CANADIAN PATIENTS: Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant) during therapy. Highly effective contraception is defined as hormonal contraceptives (oral contraceptives, Nuvaring, Depo Provera), intrauterine device, true abstinence, two barrier methods of birth control including condoms with cervical cap or diaphragm
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 within 6 months before enrollment
Additional locations may be listed on ClinicalTrials.gov for NCT05076942.
I. Investigate the safety of replacing inguinofemoral lymphadenectomy (IFL) by chemoradiation, and adjuvant (chemo) radiation when indicated, in early stage vulvar cancer patients with a macrometastasis (> 2mm) and/or extracapsular extension in the sentinel nodes (SN).
SECONDARY OBJECTIVE:
I. Evaluate the short and long-term morbidity associated with the SN procedure and chemoradiation.
OUTLINE:
Within 6-8 weeks after surgery, patients undergo radiation therapy daily for 5 weeks. Patients also receive cisplatin intravenously (IV) over 2 hours on days 1, 8, 15, 22, and 29 of radiotherapy. Patients with renal damage or co-existing diseases may receive carboplatin IV over 30 minutes on days 1, 8, 15, 22, and 29 of radiotherapy instead of cisplatin. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study.
After completion of study treatment, patients are followed up every 3-6 months for 2 years.
