Clinical Trials

2 studies in Vulvar Cancer

1. Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy Rochester, MN View Summary
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   Observation in Patients With Early-Stage Vulvar Cancer Following Surgery and/or Radiation Therapy

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   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.

   NCT ID:

   NCT01500512

   IRB Number:

   12-007759

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2. Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy for endometrial (uterine), cervical, or vulvar cancer. - To identify risk factors for the development of lower extremity lymphedema following radical surgery and to develop a corresponding predictive model. Secondary - To identify the effect that lower extremity lymphedema has on quality of life (QOL) of these patients, as assessed by Functional Assessment of Cancer Therapy/Impact of Events Scale [FACT- IES]. - To explore if patient self-reported symptoms are associated with the development of lymphedema. - To explore the effect of moderate or severe lymphedema on QOL outcomes, as measured by the FACT-G questionnaire. OUTLINE: This is a multicenter study. Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route. Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling. Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months. Psychosocial variables and quality of life is assessed periodically by the FACT-G, FACT-Cx, FACT-V, Impact of Event Scale (IES), Lymphedema Symptoms Assessment, and Lymphadenopathy Assessment questionnaires. Patients also complete a self-reported symptom questionnaire. PROJECTED ACCRUAL: A total of 500 patients with endometrial cancer, 500 with cervical cancer, and 300 with vulvar cancer will be accrued for this study.

   NCT ID:

   NCT00956670

   IRB Number:

   12-007809

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