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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002706 |
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 |
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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 |
Estimated Enrollment: | 2550 |
Study Start Date: | April 1996 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Joan L. Walker, MD | Oklahoma University Cancer Institute |
Study ID Numbers: | CDR0000064513, GOG-LAP2 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002706 History of Changes |
Health Authority: | United States: Federal Government |
stage I endometrial carcinoma stage II endometrial carcinoma endometrial adenocarcinoma stage I uterine sarcoma stage II uterine sarcoma |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Carcinoma Genital Diseases, Female Neoplasms, Connective and Soft Tissue |
Endometrial Neoplasms Malignant Mesenchymal Tumor Soft Tissue Sarcomas Uterine Sarcoma Sarcoma Uterine Neoplasms Adenocarcinoma |
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 |