Trial record 1 of 1 for:    GOG 0270
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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

December 24, 2011
August 8, 2014
January 2012
July 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety of replacing complete inguinofemoral lymphadenectomy by adjuvant radiotherapy [ Designated as safety issue: No ]
  • Short- and long-term morbidity associated with the sentinel lymph node procedure and adjuvant (chemo)radiotherapy [ Designated as safety issue: No ]
  • Safety of omitting complete inguinofemoral lymphadenectomy [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01500512 on ClinicalTrials.gov Archive Site
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Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy
Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients with early-stage vulvar cancer

  • 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
    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
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.
Interventions:
  • Other: clinical observation
  • Procedure: sentinel lymph node biopsy
  • Procedure: therapeutic conventional surgery
  • Procedure: therapeutic lymphadenectomy
  • Radiation: selective external radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
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July 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States,   Canada
 
NCT01500512
GOG-0270, NCI-2012-00100, CDR0000721346, GOG-0270, GOG-0270, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Brian Slomovitz Gynecologic Oncology Group
Gynecologic Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP