Trial record 1 of 107 for:
Vulvar Cancer: Clinical Trials
Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy
This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01500512
First received: December 24, 2011
Last updated: November 1, 2012
Last verified: October 2012
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Purpose
RATIONALE: 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.
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.
| Condition | Intervention |
|---|---|
|
Long-term Effects Secondary to Cancer Therapy in Adults Vulvar Cancer |
Other: clinical observation Procedure: adjuvant therapy Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery Procedure: therapeutic lymphadenectomy Radiation: selective external radiation therapy |
| Study Type: | Observational |
| 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | December 2036 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
- To evaluate the short- and long-term morbidity associated with the sentinel lymph node procedure and adjuvant (chemo)radiotherapy.
- To further establish the safety of omitting complete inguinofemoral lymphadenectomy in patients with a negative sentinel node.
- 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 |
Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
- No concurrent intensity-modulated radiation therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500512
Locations
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Recruiting |
| Springfield, Massachusetts, United States, 01199 | |
| Contact: Tashanna K.N. Myers 413-794-9338 | |
| United States, Nevada | |
| Women's Cancer Center - La Canada | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| Contact: Nick M. Spirtos, MD 408-866-3843 | |
| United States, New Jersey | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Recruiting |
| Morristown, New Jersey, United States, 07960 | |
| Contact: Brian M. Slomovitz 973-971-6100 | |
| United States, Ohio | |
| Riverside Methodist Hospital Cancer Care | Recruiting |
| Columbus, Ohio, United States, 43214-3998 | |
| Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C 614-566-4475 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| Cancer Care Associates - Saint Francis Campus | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Robert S. Mannel, MD 405-271-8787 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| United States, Virginia | |
| Carilion Gynecologic Oncology Associates | Recruiting |
| Roanoke, Virginia, United States, 24016 | |
| Contact: Dennis R. Scribner, MD 540-345-8574 | |
| Canada, Ontario | |
| Odette Cancer Centre at Sunnybrook | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Allan Covens, MD 416-480-4026 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Principal Investigator: | Brian Slomovitz, MD | Carol G. Simon Cancer Center at Morristown Memorial Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01500512 History of Changes |
| Other Study ID Numbers: | CDR0000721346, GOG-0270 |
| Study First Received: | December 24, 2011 |
| Last Updated: | November 1, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
long-term effects secondary to cancer therapy in adults squamous cell carcinoma of the vulva stage IA vulvar cancer stage IB vulvar cancer stage II vulvar cancer |
Additional relevant MeSH terms:
|
Vulvar Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Vulvar Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013