Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: 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.

PURPOSE: 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.

Further Study Information

OBJECTIVES:

• 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.

• Compare the length of hospital stay after surgery in patients receiving these treatments.

• Compare the quality of life of patients receiving these treatments.

• 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.

PROJECTED ACCRUAL: A total of 2,550 patients will be accrued for this study within at least 10 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times normal

• SGOT no greater than 3 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Prior malignancy allowed if no current evidence of disease

• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior pelvic or abdominal radiotherapy

Surgery:

• See Disease Characteristics

• No prior retroperitoneal surgery

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

Joan L. Walker

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002706
Information obtained from ClinicalTrials.gov on December 18, 2012

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