Trial record 3 of 25 for:    Open Studies | "Vulvar Neoplasms"

Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy

This study is currently recruiting participants.
Verified March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01500512
First received: December 24, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Long-term Effects Secondary to Cancer Therapy in Adults
Squamous Cell Carcinoma of the Vulva
Stage I Vulvar Cancer
Stage II Vulvar Cancer
Stage III Vulvar Cancer
Other: clinical observation
Procedure: sentinel lymph node biopsy
Procedure: therapeutic conventional surgery
Procedure: therapeutic lymphadenectomy
Radiation: selective external radiation therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Safety of replacing complete inguinofemoral lymphadenectomy by adjuvant radiotherapy [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Short- and long-term morbidity associated with the sentinel lymph node procedure and adjuvant (chemo)radiotherapy [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Safety of omitting complete inguinofemoral lymphadenectomy [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment (observation)
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.
Other: clinical observation
Undergo observation
Other Name: observation
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node dissection
Other Name: sentinel node biopsy
Procedure: therapeutic conventional surgery
Undergo surgery
Procedure: therapeutic lymphadenectomy
Undergo lymphadenectomy
Radiation: selective external radiation therapy
Undergo radiation therapy
Other Name: SERT

Detailed Description:

PRIMARY OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient with early stage vulvar cancer

Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500512

Locations
United States, Arizona
Gynecologic Oncology Group of Arizona Recruiting
Phoenix, Arizona, United States, 85012
Contact: Brian M. Slomovitz    973-971-5900    brian.slomovitz@atlantichealth.org   
Principal Investigator: Brian M. Slomovitz         
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Bradley J. Monk    602-406-7730    bradley.monk@chw.edu   
Principal Investigator: Bradley J. Monk         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Julia A. Chapman    913-588-4709      
Principal Investigator: Julia A. Chapman         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Tashanna K. Myers    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Tashanna K. Myers         
United States, Missouri
CoxHealth South Hospital Active, not recruiting
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Active, not recruiting
Springfield, Missouri, United States, 65802
United States, Nevada
Women's Cancer Center of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Brian M. Slomovitz    973-971-5900      
Principal Investigator: Brian M. Slomovitz         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Brian M. Slomovitz    973-971-5900      
Principal Investigator: Brian M. Slomovitz         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Shamshad Ali    716-845-5702    ali@gogstats.org   
Principal Investigator: Shamshad Ali         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mario M. Leitao    212-639-7202      
Principal Investigator: Mario M. Leitao         
United States, Ohio
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
United States, Oklahoma
University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute Active, not recruiting
Tulsa, Oklahoma, United States, 74146
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Richard G. Moore    401-274-1122      
Principal Investigator: Richard G. Moore         
United States, Texas
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Charles Levenback    713-745-2563    clevenba@mdanderson.org   
Principal Investigator: Charles Levenback         
United States, Virginia
Carilion Clinic Gynecological Oncology Recruiting
Roanoke, Virginia, United States, 24016
Contact: Janet L. Osborne    540-985-8510      
Principal Investigator: Janet L. Osborne         
Canada, Ontario
Odette Cancer Centre- Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Allan L. Covens    416-480-5000      
Principal Investigator: Allan L. Covens         
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Brian Slomovitz Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01500512     History of Changes
Other Study ID Numbers: GOG-0270, NCI-2012-00100, CDR0000721346, GOG-0270, GOG-0270, U10CA027469
Study First Received: December 24, 2011
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vulvar Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 23, 2014