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

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ClinicalTrials.gov Identifier: NCT00002706
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Adenocarcinoma Stage I Uterine Corpus Cancer Stage I Uterine Sarcoma Stage II Uterine Corpus Cancer Stage II Uterine Sarcoma Procedure: Laparoscopic Surgery Other: Quality-of-Life Assessment Procedure: Therapeutic Conventional Surgery Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III
Study Start Date : April 1996
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I
Patients undergo vaginal hysterectomy and BSO via laparoscopy.
Procedure: Laparoscopic Surgery
Undergo vaginal hysterectomy and BSO via laparoscopy
Other Names:
  • laparoscopic-assisted resection
  • laparoscopy-assisted surgery
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Active Comparator: Arm II
Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Procedure: Therapeutic Conventional Surgery
Undergo total abdominal hysterectomy and BSO via conventional laparotomy



Primary Outcome Measures :
  1. Duration of disease-free interval [ Time Frame: Up to 5 years ]
    The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.

  2. Frequency of aborting LAVH in order to perform an TAH/BSO [ Time Frame: Up to 5 years ]
  3. Frequency of major surgical complications, graded according to the NCI CTC and classified as either less than grade 2 or grade 2 or worse [ Time Frame: Up to 5 years ]
  4. Length of hospitalization following surgery [ Time Frame: From the date of surgery to the date of discharge, assessed up to 5 years ]
    A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.

  5. Self assessed quality of life scores as measured by FACT-G, Physical Function Subscale from the MOS SF-36, Wisconsin Brief Pain Inventory, Fear of Relapse/Recurrence scale, and Personal Appearance scale [ Time Frame: Up to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002706


Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joan Walker Gynecologic Oncology Group

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00002706     History of Changes
Other Study ID Numbers: GOG-LAP2
NCI-2012-02237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000064513
GOG-LAP2 ( Other Identifier: Gynecologic Oncology Group )
GOG-LAP2 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

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