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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 3

Conditions: Stage I Uterine Corpus Cancer; Endometrial Adenocarcinoma; Stage I Uterine Sarcoma; Stage II Uterine Sarcoma; Stage II Uterine Corpus Cancer

Treatments: Procedure: Laparoscopic Surgery; Procedure: Therapeutic Conventional Surgery; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00002706

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000064513

NCI-2012-02237 (Registry Identifier)

GOG-LAP2 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,616 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,616 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients undergo vaginal hysterectomy and BSO via laparoscopy.

Treatment:

Other: Quality-of-Life Assessment

Procedure: Laparoscopic Surgery

Arm II

Active Comparator group

Description:

Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.

Treatment:

Procedure: Therapeutic Conventional Surgery

Other: Quality-of-Life Assessment