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Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
This study is ongoing, but not recruiting participants.
Study NCT00002706   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: October 10, 2009   History of Changes

November 1, 1999
October 10, 2009
April 1996
 
  • Compare laparoscopy vs laparotomy surgical staging & results by conversion from laparoscopy to laparotomy [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy surgical staging & results by length of operative time [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy surgical staging & results by length of hospital stay [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy surgical staging & results by transfusions [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy surgical staging & results by deaths in 6 weeks [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy surgical staging & results by readmission [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy surgical staging & results by reoperations [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy surgical staging & results by complications during operation and for 6 weeks after surgery [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy for pathologic staging by nodes obtained from right and left pelvic and right and left para-aortic nodes [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy for pathologic staging by pelvic washing for cytology node counts [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy for pathologic staging by node positivity rates [ Designated as safety issue: No ]
  • Compare laparoscopy vs laparotomy for pathologic staging by surgical stage after surgery [ Designated as safety issue: No ]
  • Pattern of recurrence as assessed by the location of the first site of recurrence after 5 years [ Designated as safety issue: No ]
  • Progression-free survival every 3 months for 2 years and every 6 months for 5 years [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00002706 on ClinicalTrials.gov Archive Site
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 [ Designated as safety issue: No ]
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
 
Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
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

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.

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.

Phase III
Interventional
Treatment, Randomized, Active Control
  • Endometrial Cancer
  • Sarcoma
  • Procedure: conventional surgery
  • Procedure: laparoscopic surgery
 
Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy Compared With Laparotomy for Comprehensive Surgical Staging of Uterine Cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Oct 5; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2550
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00002706
 
CDR0000064513, GOG-LAP2
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Joan L. Walker, MD Oklahoma University Cancer Institute
National Cancer Institute (NCI)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP