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

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002706
Collaborator
National Cancer Institute (NCI) (NIH)
2,616
Enrollment
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic Surgery
  • Other: Quality-of-Life Assessment
  • Procedure: Therapeutic Conventional Surgery
 Phase 3

Detailed Description

OBJECTIVES:

  1. 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.

  2. Compare the length of hospital stay after surgery in patients receiving these treatments.

  3. 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 Design

Study Type:
Interventional
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 :
Apr 1, 1996
Actual Primary Completion Date :
Mar 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • Quality of Life Assessment

    • Procedure: Therapeutic Conventional Surgery
    Undergo total abdominal hysterectomy and BSO via conventional laparotomy

    Outcome Measures

    Primary Outcome Measures

    1. Duration of disease-free interval [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 [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 [Up to 5 years]

    4. Length of hospitalization following surgery [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 [Up to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00002706
    Other Study ID Numbers:
    • GOG-LAP2
    • NCI-2012-02237
    • CDR0000064513
    • GOG-LAP2
    • GOG-LAP2
    • U10CA027469
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    May 29, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Adenocarcinoma
    Sarcoma
    Uterine Neoplasms

    Study Results

    No Results Posted as of May 29, 2015