Brief Summary

This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,055

participants targeted

Target at P75+ for not_applicable

Geographic Reach

1 country

213 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed

2.8 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

August 8, 2009

Last Update Submit

May 3, 2017

Conditions

Lymphedema Stage IA Cervical Cancer Stage IA Uterine Corpus Cancer Stage IA Vulvar Cancer Stage IB Cervical Cancer Stage IB Uterine Corpus Cancer Stage IB Vulvar Cancer Stage II Uterine Corpus Cancer Stage II Vulvar Cancer Stage IIA Cervical Cancer Stage IIIA Vulvar Cancer Stage IIIB Vulvar Cancer Stage IIIC Vulvar Cancer Stage IVB Vulvar Cancer

Outcome Measures

Primary Outcomes (2)

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
A competing risks analysis will be required to estimate the cumulative incidence of lymphedema. Transition probabilities in the Markov Chain will be estimated by simple proportions, ignoring covariates, to address this primary objective. Confidence intervals for the cumulative incidence of lymphedema then will be computed using the Delta Method, utilizing the fact that the transition proportions have and asymptotic multivariate normal distribution.
Up to 24 months
Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers
If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.
Up to 24 months

Secondary Outcomes (3)

Patient self-reported symptoms
Up to 24 months
Quality of life
Up to 24 months
Risk factors for the development of lower extremity lymphoma in patients with cervical cancers
Up to 24 months

Study Arms (1)

Supportive care (lymphedema assessment)

EXPERIMENTAL

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.

Other: Quality-of-Life AssessmentOther: Questionnaire AdministrationProcedure: Study of High Risk FactorsProcedure: Therapeutic Conventional SurgeryProcedure: Therapeutic Laparoscopic SurgeryProcedure: Therapeutic Lymphadenectomy