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Surgery-Related Lymphedema for Uterine and Gynecologic Cancers (LEG Trial)

N/A
Waitlist Available
Led By Richard Barakat
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgery must occur within 5 business days before study entry or within eight weeks after study entry
Be older than 18 years old
Must not have
Patients who enter the study and then undergo sentinel node biopsy without the intention of undergoing complete lymphadenectomy
Patients with a prior history of chronic lower extremity swelling
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trial looks at lymphedema after surgery in patients with endometrial, cervical, or vulvar cancer.

Who is the study for?
This trial is for patients with endometrial, cervical, or vulvar cancer who are undergoing or have undergone specific surgeries like radical hysterectomy and lymphadenectomy. They must consent to health information release, have a serum albumin level of >= 3.0 within two weeks before joining the study, and their surgery should be close to the study entry date. Those with prior lower extremity swelling, vascular surgeries, radiation therapy in affected areas, other elective surgeries during the same event as their lymphadenectomy or certain chronic diseases are excluded.
What is being tested?
The trial studies how often lymphedema occurs after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer by collecting quality-of-life data over time through questionnaires and assessing high-risk factors related to therapeutic conventional surgery and laparoscopic techniques.
What are the potential side effects?
While this study focuses on monitoring conditions post-surgery rather than testing medications directly, potential side effects may include complications from surgical procedures such as pain at the incision site(s), infection risk increase due to lymph node removal (lymphadenectomy), possible long-term swelling of limbs (lymphedema), and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My surgery is scheduled within 5 days before or 8 weeks after joining the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a sentinel node biopsy without plans for complete lymph node removal.
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I have a history of chronic swelling in my legs.
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I have had radiation therapy in the pelvic, abdominal, inguinal, or leg area.
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I am having or had another surgery besides lymph node removal for pelvic or vulvar cancer.
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I have not had surgery to remove lymph nodes.
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I have had surgery on the blood vessels in my legs.
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I have a history of heart failure, kidney, or liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of lymphedema, assessed through volumetric measurements using serial circumferential measurements performed from 10 cm above the heel to the inguinal crease at 10 cm intervals
Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers
Secondary study objectives
Patient self-reported symptoms
Quality of life
Risk factors for the development of lower extremity lymphoma in patients with cervical cancers

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (lymphedema assessment)Experimental Treatment6 Interventions
Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014) 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Study of High Risk Factors
2010
N/A
~1920
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870

Find a Location

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
64,126 Total Patients Enrolled
4 Trials studying Lymphedema
346 Patients Enrolled for Lymphedema
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,001,945 Total Patients Enrolled
31 Trials studying Lymphedema
13,275 Patients Enrolled for Lymphedema
Richard BarakatPrincipal InvestigatorNRG Oncology

Media Library

Therapeutic Conventional Surgery Clinical Trial Eligibility Overview. Trial Name: NCT00956670 — N/A
Lymphedema Research Study Groups: Supportive care (lymphedema assessment)
Lymphedema Clinical Trial 2023: Therapeutic Conventional Surgery Highlights & Side Effects. Trial Name: NCT00956670 — N/A
Therapeutic Conventional Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT00956670 — N/A
Lymphedema Patient Testimony for trial: Trial Name: NCT00956670 — N/A
~80 spots leftby Sep 2025
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