Expired Study
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Philadelphia, Pennsylvania 19103


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. 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.


Study summary:

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.


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


Study is Available At:


Original ID:

GOG-LAP2


NCT ID:

NCT00002706


Secondary ID:

NCI-2012-02237


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Group


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

2616


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joan Walker
Principal Investigator
Gynecologic Oncology Group

Study Dates

Start Date:April 1996
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:May 2015
Last Changed Date:May 27, 2015
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Length of hospitalization following surgery
Time Frame:From the date of surgery to the date of discharge, assessed up to 5 years
Safety Issues:False
Description:A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors.
Outcome Type:Primary Outcome
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
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Frequency of aborting LAVH in order to perform an TAH/BSO
Time Frame:Up to 5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Duration of disease-free interval
Time Frame:Up to 5 years
Safety Issues:False
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.

Study Interventions

Intervention Type:Procedure
Name:Laparoscopic Surgery
Description:Undergo vaginal hysterectomy and BSO via laparoscopy
Arm Name:Arm I
Other Name:Laparoscopic Surgery
Intervention Type:Other
Name:Quality-of-Life Assessment
Description:Ancillary studies
Arm Name:Arm I
Other Name:Quality of Life Assessment
Intervention Type:Procedure
Name:Therapeutic Conventional Surgery
Description:Undergo total abdominal hysterectomy and BSO via conventional laparotomy
Arm Name:Arm II

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm II
Description:Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Study Arm Type:Experimental
Arm Name:Arm I
Description:Patients undergo vaginal hysterectomy and BSO via laparoscopy.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Barakat R, Pearl ML, Sharma SK. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012 Mar 1;30(7):695-700. doi: 10.1200/JCO.2011.38.8645. Epub 2012 Jan 30. Erratum in: J Clin Oncol. 2012 May 1;30(13):1570.
PMID:22291074
Reference Type:Results Reference
Citation:Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.
PMID:19805679
Reference Type:Results Reference
Citation: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.
Reference Type:Results Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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