Overview

This trial is active, not recruiting.

Conditions lymphedema, perioperative/postoperative complications, stage ia vulvar cancer, stage ib vulvar cancer, stage ii vulvar cancer, stage iiia vulvar cancer, stage iiib vulvar cancer, stage iiic vulvar cancer, stage iva vulvar cancer, stage ivb vulvar cancer
Treatments bioelectric impedance analysis, lymphadenectomy, therapeutic conventional surgery
Phase phase 2
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date July 2012
End date July 2017
Trial size 120 participants
Trial identifier NCT01406769, CDR0000706551, GOG-0269, NCI-2011-03798, U10CA101165

Summary

This phase II trial studies bioimpedance spectroscopy in detecting lower-extremity lymphedema in patients with stage I, stage II, stage III, or stage IV vulvar cancer undergoing surgery and lymphadenectomy. Diagnostic procedures, such as bioimpedance spectroscopy, may help doctors to predict the onset of lower-extremity lymphedema in patients with vulvar cancer undergoing surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients undergo preoperative and postoperative lower-extremity lymphedema assessment comprising serial circumferential measurements, bioimpedance spectroscopy measurements, and clinical evaluation using the Stemmer sign. Patients undergo radical vulvectomy or radical local excision as prescribed by GOG-0244, and unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy.
bioelectric impedance analysis BIA
Undergo preoperative and postoperative lower-extremity lymphedema assessment
lymphadenectomy excision of the lymph node
Undergo lymphadenectomy
therapeutic conventional surgery
Undergo radical vulvectomy or radical local excision

Primary Outcomes

Measure
Frequency and severity of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
time frame: Up to 24 months
Sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements (limb volume and Stemmer Sign)
time frame: Up to 24 months post-operatively

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Patients with vulvar cancer already enrolled onto Gynecologic Oncology Group (GOG)-0244 who will undergo or have undergone definitive surgery for primary stage I-IV vulvar cancer who will receive a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy; - Patients who are going to receive multi-modality therapy (radiation +/- chemotherapy) after undergoing surgery are eligible - Patients who have met the pre-entry requirements - Patients must have signed an approved informed consent and authorization permitting release of personal health information for GOG-0269 and for GOG-0244 - Patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy during the same operative event - Serum Albumin level of >= 3.0 within 14 days of entry - Patients with a GOG performance status of 0, 1, or 2 Exclusion Criteria: - Patients not enrolled onto GOG-0244 - Patients with any prior clinical history of lower extremity lymphedema - Patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease - Patients with a prior history of chronic lower extremity swelling - Patients with a GOG Performance Grade of 3 or 4 - Patients with a history of other invasive malignancies if that malignancy included a bilateral lymph node procedure (example: bilateral mastectomies and axillary lymphadenectomies) or if their previous cancer treatment included any of the surgical procedures - Patients who have had prior lower extremity vascular surgery (arterial or venous) - Patients who have had prior pelvic bilateral axillary or any pelvic, abdominal, inguinal, or lower extremity radiation therapy - Patients who are going to receive another elective surgery during the same operative event as their inguinal lymphadenectomy and vulvar surgery - Patients who undergo sentinel node biopsy without the intention of undergoing a complete lymphadenectomy during that same operative event - Patients with an implanted cardiac device such as a pacemaker or implantable cardioverter defibrillator - Patients who are pregnant or currently breastfeeding - Patients who have been treated for, or are at risk of, bilateral arm lymphedema - Patients with an allergic reaction to electrocardiogram (EKG) electrodes - Patients who have had bilateral auxiliary dissection

Additional Information

Official title A Limited Access Phase II Trial Utilizing Bioimpedance to Measure Lower Extremity Lymphedema Associated With the Surgical Management of a Vulvar Cancer
Principal investigator Jay Carlson
Description OBJECTIVES: I. To evaluate the sensitivity, specificity, and feasibility of bioimpedance technology as compared to clinically derived measurements to include circumferential volumetric measurements to detect lower-extremity lymphedema in patients who are undergoing an inguinal lymphadenectomy during the concurrent surgical management of a vulvar cancer. OUTLINE: This is a multicenter study. Patients undergo preoperative and postoperative lower-extremity lymphedema assessment comprising serial circumferential measurements, bioimpedance spectroscopy measurements, and clinical evaluation using the Stemmer sign. Patients undergo radical vulvectomy or radical local excision as prescribed by GOG-0244, and unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy. After completion of study, patients are followed up at 4-6 weeks, every 3 months for 1 year, and then every 6 months for 1 year.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.