Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2616 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Laparoscopic Approach to Cervical Cancer

NCT00614211

Cervical Cancer

COMPLETED NA

Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy)

NCT06790004

Endometrial Carcinoma

ACTIVE_NOT_RECRUITING

Comparison of Five-year Survival and Disease-free Survival in Patients Diagnosed With Endometrium Cancer Who Underwent Total Laparoscopic Hysterectomy With and Without Uterine Manipulator

NCT06307886

Endometrial Cancer

RECRUITING

Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

NCT01466777

Endometrium Cancer

UNKNOWN NA

Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy

NCT05969405

Endometrial Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Adenocarcinoma Stage I Uterine Corpus Cancer Stage I Uterine Sarcoma Stage II Uterine Corpus Cancer Stage II Uterine Sarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I

Patients undergo vaginal hysterectomy and BSO via laparoscopy.

Group Type EXPERIMENTAL

Laparoscopic Surgery

Intervention Type PROCEDURE

Undergo vaginal hysterectomy and BSO via laparoscopy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II

Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.

Group Type ACTIVE_COMPARATOR

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Therapeutic Conventional Surgery

Intervention Type PROCEDURE

Undergo total abdominal hysterectomy and BSO via conventional laparotomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic Surgery

Undergo vaginal hysterectomy and BSO via laparoscopy

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Therapeutic Conventional Surgery

Undergo total abdominal hysterectomy and BSO via conventional laparotomy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

laparoscopic-assisted resection laparoscopy-assisted surgery Quality of Life Assessment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No