Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI GOG-LAP2 NCT00002706

Objectives

1. 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.
2. Compare the length of hospital stay after surgery in patients receiving these treatments.
3. Compare the quality of life of patients receiving these treatments.
4. Compare the incidence and location of disease recurrence in patients receiving these treatments.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Compare laparoscopy vs laparotomy surgical staging & results by conversion from laparoscopy to laparotomy
Compare laparoscopy vs laparotomy surgical staging & results by length of operative time
Compare laparoscopy vs laparotomy surgical staging & results by length of hospital stay
Compare laparoscopy vs laparotomy surgical staging & results by transfusions
Compare laparoscopy vs laparotomy surgical staging & results by deaths in 6 weeks
Compare laparoscopy vs laparotomy surgical staging & results by readmission
Compare laparoscopy vs laparotomy surgical staging & results by reoperations
Compare laparoscopy vs laparotomy surgical staging & results by complications during operation and for 6 weeks after surgery
Compare laparoscopy vs laparotomy for pathologic staging by nodes obtained from right and left pelvic and right and left para-aortic nodes
Compare laparoscopy vs laparotomy for pathologic staging by pelvic washing for cytology node counts
Compare laparoscopy vs laparotomy for pathologic staging by node positivity rates
Compare laparoscopy vs laparotomy for pathologic staging by surgical stage after surgery
Pattern of recurrence as assessed by the location of the first site of recurrence after 5 years
Progression-free survival every 3 months for 2 years and every 6 months for 5 years

Quality of life as assessed by FACT-G, body image, sexual function, SF-36, BPI, personal appearance, and return to work before surgery, at 1, 6 weeks, and 1 year

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.

Walker JL, Piedmonte M, Spirtos N, et al.: Surgical staging of uterine cancer: randomized phase III trial of laparoscopy vs laparotomy--A Gynecologic Oncology Group study (GOG): preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-5010, 2006.

Walker J, Piedmonte M, Spirtos N, et al.: Phase III trial of laparoscopy (scope) vs laparotomy (open) for surgical resection and comprehensive surgical staging of uterine cancer: a Gynecologic Oncology Group (GOG) study funded by NCI. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-22, 2006.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Joan Walker, MD, Protocol chair		Ph: 405-271-8707

Registry Information
Official Title		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, Clinical Stage I, IIA, Grade I, II, III
Trial Start Date		1996-04-01
Registered in ClinicalTrials.gov		NCT00002706
Date Submitted to PDQ		1996-04-01
Information Last Verified		2005-09-20
NCI Grant/Contract Number		U10-CA27469

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