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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~9890