NCT00002706

Brief Summary

This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
2,616

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

13.9 years

First QC Date

November 1, 1999

Last Update Submit

May 27, 2015

Conditions

Endometrial AdenocarcinomaStage I Uterine Corpus CancerStage I Uterine SarcomaStage II Uterine Corpus CancerStage II Uterine Sarcoma

Outcome Measures

Primary Outcomes (5)

  • Duration of disease-free interval

    The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.

    Up to 5 years

  • Frequency of aborting LAVH in order to perform an TAH/BSO

    Up to 5 years

  • Frequency of major surgical complications, graded according to the NCI CTC and classified as either less than grade 2 or grade 2 or worse

    Up to 5 years

  • Length of hospitalization following surgery

    A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.

    From the date of surgery to the date of discharge, assessed up to 5 years

  • Self assessed quality of life scores as measured by FACT-G, Physical Function Subscale from the MOS SF-36, Wisconsin Brief Pain Inventory, Fear of Relapse/Recurrence scale, and Personal Appearance scale

    Up to 6 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients undergo vaginal hysterectomy and BSO via laparoscopy.

Procedure: Laparoscopic SurgeryOther: Quality-of-Life Assessment

Arm II

ACTIVE COMPARATOR

Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.

Other: Quality-of-Life AssessmentProcedure: Therapeutic Conventional Surgery

Interventions

Laparoscopic SurgeryPROCEDURE

Undergo vaginal hysterectomy and BSO via laparoscopy

Also known as: laparoscopic-assisted resection, laparoscopy-assisted surgery
Arm I
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Arm IArm II
Therapeutic Conventional SurgeryPROCEDURE

Undergo total abdominal hysterectomy and BSO via conventional laparotomy

Arm II

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma
  • Must be considered a candidate for surgery
  • No contraindication to laparoscopy
  • No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix
  • Performance status - GOG 0-3
  • WBC at least 3,000/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Creatinine no greater than 2.0 mg/dL
  • Prior malignancy allowed if no current evidence of disease
  • Not pregnant
  • No prior pelvic or abdominal radiotherapy
  • See Disease Characteristics
  • No prior retroperitoneal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

  • Bishop EA, Java JJ, Moore KN, Spirtos NM, Pearl ML, Zivanovic O, Kushner DM, Backes F, Hamilton CA, Geller MA, Hurteau J, Mathews C, Wenham RM, Ramirez PT, Zweizig S, Walker JL. Surgical outcomes among elderly women with endometrial cancer treated by laparoscopic hysterectomy: a NRG/Gynecologic Oncology Group study. Am J Obstet Gynecol. 2018 Jan;218(1):109.e1-109.e11. doi: 10.1016/j.ajog.2017.09.026. Epub 2017 Oct 14.

    PMID: 29037481DERIVED

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Joan Walker

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1996

Primary Completion

March 1, 2010

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

US(1)