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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date May 29, 2015
Study Start Date  ICMJE April 1996
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • 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.
  • Frequency of aborting LAVH in order to perform an TAH/BSO [ Time Frame: Up to 5 years ]
  • 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 ]
  • 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.
  • 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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Adenocarcinoma
  • Stage I Uterine Corpus Cancer
  • Stage I Uterine Sarcoma
  • Stage II Uterine Corpus Cancer
  • Stage II Uterine Sarcoma
Intervention  ICMJE
  • 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
  • Procedure: Therapeutic Conventional Surgery
    Undergo total abdominal hysterectomy and BSO via conventional laparotomy
Study Arms  ICMJE
  • Experimental: Arm I
    Patients undergo vaginal hysterectomy and BSO via laparoscopy.
    Interventions:
    • Procedure: Laparoscopic Surgery
    • Other: Quality-of-Life Assessment
  • Active Comparator: Arm II
    Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
    Interventions:
    • Other: Quality-of-Life Assessment
    • Procedure: Therapeutic Conventional Surgery
Publications * Bishop EA, Java JJ, Moore KN, Spirtos NM, Pearl ML, Zivanovic O, Kushner DM, Backes F, Hamilton CA, Geller MA, Hurteau J, Mathews C, Wenham RM, Ramirez PT, Zweizig S, Walker JL. Surgical outcomes among elderly women with endometrial cancer treated by laparoscopic hysterectomy: a NRG/Gynecologic Oncology Group study. Am J Obstet Gynecol. 2018 Jan;218(1):109.e1-109.e11. doi: 10.1016/j.ajog.2017.09.026. Epub 2017 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2015)
2616
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00002706
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Joan Walker Gynecologic Oncology Group
PRS Account Gynecologic Oncology Group
Verification Date May 2015

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