Completed

A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III

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What is being tested

Laparoscopic Surgery

+ Quality-of-Life Assessment

+ Quality-of-Life Assessment

ProcedureOther
Who is being recruted

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 1996
See protocol details

Summary

Principal SponsorGynecologic Oncology Group
Last updated: May 29, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1996

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy. II. Compare the length of hospital stay after surgery in patients receiving these treatments. III. Compare the quality of life of patients receiving these treatments. IV. Compare the incidence and location of disease recurrence in patients receiving these treatments. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo vaginal hysterectomy and bilateral salpingo-oophorectomy (BSO) via laparoscopy. ARM II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy. Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months. Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

NCT00002706
Principal SponsorGynecologic Oncology Group
Last updated: May 29, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2616 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

15 inclusion criteria required to participate
SGOT no greater than 3 times normal

No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix

Performance status - GOG 0-3

Must be considered a candidate for surgery

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients undergo vaginal hysterectomy and BSO via laparoscopy.

Group II

Active Comparator
Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Gynecologic Oncology Group

Philadelphia, United StatesOpen Gynecologic Oncology Group in Google Maps
CompletedOne Study Center