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

Completed · Phase 3

Conditions studied: Endometrial Adenocarcinoma, Stage I Uterine Corpus Cancer, Stage I Uterine Sarcoma, Stage II Uterine Corpus Cancer, Stage II Uterine Sarcoma

In brief

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.

Key facts

Study ID

NCT00002706

Run by

Gynecologic Oncology Group

People needed

2616

Starts

1996-04-01

Last updated by the study team

2015-05-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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