Clinical Trials (PDQ®)
|No phase specified||Natural history/Epidemiology, Treatment||Active||18 and over||NCI, Other||GOG-0270|
NCI-2012-00100, CDR0000721346, U10CA027469, NCT01500512
This observational trial studies how well surgery to remove the tumor and lymph nodes, and/or radiation therapy work in treating patients with early-stage vulvar cancer. Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery and/or radiation therapy are in treating vulvar cancer.
Further Study Information
I. To investigate the safety of replacing complete inguinofemoral lymphadenectomy by adjuvant radiotherapy in early-stage vulvar cancer patients with a sentinel node metastasis ≤ 2 mm.
II. To evaluate the short- and long-term morbidity associated with the sentinel lymph node procedure and adjuvant (chemo) radiotherapy.
III. To further establish the safety of omitting complete inguinofemoral lymphadenectomy in patients with a negative sentinel node.
IV. To explore the efficacy, safety, and short- and long-term morbidity of inguinofemoral lymphadenectomy and radiotherapy in patients with sentinel node metastasis > 2 mm. (exploratory)
OUTLINE: This is a multicenter study.
Patients undergo planned radical vulvectomy and sentinel lymph node dissection. Patients without lymph node involvement undergo observation. Patients with minimal lymph node involvement undergo radiotherapy. Patients with significant lymph node involvement undergo inguinofemoral lymphadenectomy and radiotherapy with or without chemotherapy according to institutional guidelines.
After completion of study treatment, patients are followed up every 2 months for 2 years. Follow-up includes interview, gynecological examination, and palpation of the groins.
- Patients with squamous cell carcinoma, depth of invasion > 1 mm
- Patients with T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), tumors < 4 cm, and/or not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
- Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
- Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes
- No inoperable tumors and tumors with diameter > 4 cm
- No patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm)/suspicious groin nodes, and with cytologically proven inguinofemoral lymph node metastases
- No patients with multifocal tumors
- No concurrent intensity-modulated radiation therapy
- Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|Brian Slomovitz||Principal Investigator|
|GOG of Arizona, PC|
|Brian M Slomovitz||Ph: 973-971-5900|
|St. Joseph's Hospital and Medical Center|
|Bradley J. Monk||Ph: 602-406-7730|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center|
|Julia A. Chapman||Ph: 913-588-4709|
|Baystate Medical Center|
|Tashanna K Myers||Ph: 413-794-3565|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital|
|Brian M Slomovitz||Ph: 866-574-5124|
|Brian M Slomovitz||Ph: 866-574-5124|
|Roswell Park Cancer Institute|
|Shamshad Ali||Ph: 716-845-5702|
|Memorial Sloan-Kettering Cancer Center|
|Mario M Leitao||Ph: 212-639-7202|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Linda Van Le||Ph: 877-668-0683|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|David M O'Malley||Ph: 866-627-7616|
|UPMC Cancer Centers|
|Marilyn Huang||Ph: 412-647-2811|
|Women and Infants Hospital of Rhode Island|
|Richard G Moore||Ph: 401-274-1122|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|David Scott Miller||Ph: 214-648-7097|
|M. D. Anderson Cancer Center at University of Texas|
|Charles Levenback||Ph: 713-745-2563|
|Odette Cancer Centre at Sunnybrook|
|Allan Covens||Ph: 416-480-5000|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01500512
ClinicalTrials.gov processed this data on August 12, 2014
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