← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

LEG Trial 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.Check my eligibility
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.See study design
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.

LEG Trial Eligibility Criteria

Inclusion Criteria

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

LEG Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Patient self-reported symptoms
Quality of life
Risk factors for the development of lower extremity lymphoma in patients with cervical cancers

LEG 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
~9860

Find a Location

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
69,871 Total Patients Enrolled
4 Trials studying Lymphedema
346 Patients Enrolled for Lymphedema
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,914,591 Total Patients Enrolled
31 Trials studying Lymphedema
13,277 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which locations is this experiment being administered?

"Currently, this trial is seeking to recruit 100 patients from various sites; some of these include the University of Iowa/Holden Comprehensive Cancer Center in Iowa City, Union Hospital of Cecil County in Elkton, and Sutter Cancer Research Consortium in Novato."

Answered by AI

Are any additional participants still being accepted into this scientific experiment?

"The details hosted on clinicaltrials.gov suggest that this research project is not actively enrolling candidates at the present moment in time. It was first announced to the public on June 1st 2012 and last updated 3rd May 2017, while there are presently 419 other trials recruiting patients across a variety of healthcare specialties."

Answered by AI

Who else is applying?

What state do they live in?
California
Other
South Carolina
Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Alta Bates Summit Medical Center-Herrick Campus
California Pacific Medical Center-Pacific Campus
Aurora West Allis Medical Center

Why did patients apply to this trial?

Hoping for new trials and procedures to alleviate lymphedema. I’m want change and no pain, thanks in advance, tinabuffler1991@gmail.com.
PatientReceived 2+ prior treatments
Lymphedema for over 10 years that started in lower left foot and gradually went to abdomen.
PatientReceived 2+ prior treatments
~83 spots leftby Mar 2025