Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
This study has been completed.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002706
First received: November 1, 1999
Last updated: February 9, 2012
Last verified: September 2005
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Purpose
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 |
|---|---|---|
|
Endometrial Cancer Sarcoma |
Procedure: conventional surgery Procedure: laparoscopic surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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, Clinical Stage I, IIA, Grade I, II, III |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Compare laparoscopy vs laparotomy surgical staging & results by conversion from laparoscopy to laparotomy [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy surgical staging & results by length of operative time [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy surgical staging & results by length of hospital stay [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy surgical staging & results by transfusions [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy surgical staging & results by deaths in 6 weeks [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy surgical staging & results by readmission [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy surgical staging & results by reoperations [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy surgical staging & results by complications during operation and for 6 weeks after surgery [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy for pathologic staging by nodes obtained from right and left pelvic and right and left para-aortic nodes [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy for pathologic staging by pelvic washing for cytology node counts [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy for pathologic staging by node positivity rates [ Designated as safety issue: No ]
- Compare laparoscopy vs laparotomy for pathologic staging by surgical stage after surgery [ Designated as safety issue: No ]
- Pattern of recurrence as assessed by the location of the first site of recurrence after 5 years [ Designated as safety issue: No ]
- Progression-free survival every 3 months for 2 years and every 6 months for 5 years [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life as assessed by FACT-G, body image, sexual function, SF-36, BPI, personal appearance, and return to work before surgery, at 1, 6 weeks, and 1 year [ Designated as safety issue: No ]
| Estimated Enrollment: | 2550 |
| Study Start Date: | April 1996 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
- Compare the length of hospital stay after surgery in patients receiving these treatments.
- Compare the quality of life of patients receiving these treatments.
- 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.
PROJECTED ACCRUAL: A total of 2,550 patients will be accrued for this study within at least 10 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- GOG 0-3
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Prior malignancy allowed if no current evidence of disease
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior pelvic or abdominal radiotherapy
Surgery:
- See Disease Characteristics
- No prior retroperitoneal surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002706
Show 51 Study Locations
Show 51 Study LocationsSponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Study Chair: | Joan L. Walker, MD | Oklahoma University Cancer Institute |
More Information
Additional Information:
Publications:
Walker JL, Piedmonte M, Spirtos N, et al.: Surgical staging of uterine cancer: randomized phase III trial of laparoscopy vs laparotomy--A Gynecologic Oncology Group study (GOG): preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-5010, 2006.
Walker J, Piedmonte M, Spirtos N, et al.: Phase III trial of laparoscopy (scope) vs laparotomy (open) for surgical resection and comprehensive surgical staging of uterine cancer: a Gynecologic Oncology Group (GOG) study funded by NCI. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-22, 2006.
| ClinicalTrials.gov Identifier: | NCT00002706 History of Changes |
| Other Study ID Numbers: | CDR0000064513, GOG-LAP2 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I endometrial carcinoma stage II endometrial carcinoma endometrial adenocarcinoma stage I uterine sarcoma stage II uterine sarcoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Endometrial Neoplasms Sarcoma, Endometrial Stromal Uterine Neoplasms Adenoma Sarcoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |
ClinicalTrials.gov processed this record on June 17, 2013