Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy
Basic Trial Information
|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 Contact Information
Trial Lead Organizations/Sponsors
Gynecologic Oncology Group
- National Cancer Institute
St. Joseph's Hospital and Medical Center
Bradley J. Monk
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Julia A. Chapman
Baystate Medical Center
Tashanna K Myers
Masonic Cancer Center at University of Minnesota
Peter A Argenta
Women's Cancer Center - La Canada
Nick M. Spirtos
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Brian M Slomovitz
Brian M Slomovitz
Roswell Park Cancer Institute
Memorial Sloan-Kettering Cancer Center
Mario M Leitao
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Linda Van Le
Stephenson Cancer Center at the University of Oklahoma
Robert S. Mannel
Women and Infants Hospital of Rhode Island
Richard G Moore
M. D. Anderson Cancer Center at University of Texas
Carilion Clinic Gynecological Oncology
Janet L. Osborne
Odette Cancer Centre at Sunnybrook
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01500512
ClinicalTrials.gov processed this data on May 07, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.