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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 8, 2014
Last verified: August 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

Patients 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500512

  Show 23 Study Locations
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: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Vulvar Neoplasms
Carcinoma
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 September 16, 2014