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NCT00002706 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2015-05-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo vaginal hysterectomy and BSO via laparoscopy.
    intervention Names
    1. Procedure: Laparoscopic Surgery
    2. Other: Quality-of-Life Assessment
    label
    Arm I
    type
    EXPERIMENTAL
  2. description
    Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
    intervention Names
    1. Other: Quality-of-Life Assessment
    2. Procedure: Therapeutic Conventional Surgery
    label
    Arm II
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I
    description
    Undergo vaginal hysterectomy and BSO via laparoscopy
    name
    Laparoscopic Surgery
    other Names
    1. laparoscopic-assisted resection
    2. laparoscopy-assisted surgery
    type
    PROCEDURE
  2. arm Group Labels
    1. Arm I
    2. Arm II
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  3. arm Group Labels
    1. Arm II
    description
    Undergo total abdominal hysterectomy and BSO via conventional laparotomy
    name
    Therapeutic Conventional Surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2616
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures.
    measure
    Duration of disease-free interval
    time Frame
    Up to 5 years
  2. measure
    Frequency of aborting LAVH in order to perform an TAH/BSO
    time Frame
    Up to 5 years
  3. measure
    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. description
    A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.
    measure
    Length of hospitalization following surgery
    time Frame
    From the date of surgery to the date of discharge, assessed up to 5 years
  5. measure
    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
Full study description
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.
Source references
references
  1. citation
    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.
    pmid
    29037481
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        r significant at 6 months.[<a href="#cit/section_5.20">20</a>,<a href="#cit/section_5.21">21</a>]</li></ul></div></li><li>A GOG trial (<a href="/clinicaltrials/NCT00002706">GOG-LAP2</a>) randomly assigned 2,616 patients with clinical stages I to IIA disease in a 2:1 ratio to comprehensive surgical staging via laparoscopy or lapar
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      source retrieved at
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      source string sha256
      214764f794ad4552aa24a0de383a8f709f829c4235c5afce99f2ac45b04d7b7d
      source title
      Endometrial Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice