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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.
First Received: November 1, 1999   Last Updated: October 10, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002706
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Sarcoma
 Procedure: conventional surgery
Procedure: laparoscopic surgery
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hysterectomy Soft Tissue Sarcoma Surgery Uterine Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2550
Study Start Date: April 1996
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002706

  Show 51 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Joan L. Walker, MD Oklahoma University Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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]
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.

Study ID Numbers: CDR0000064513, GOG-LAP2
Study First Received: November 1, 1999
Last Updated: October 10, 2009
ClinicalTrials.gov Identifier: NCT00002706     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma
stage I uterine sarcoma
stage II uterine sarcoma

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms
Endometrial Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
 Genital Neoplasms, Female
Sarcoma
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009



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