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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02237 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000064513 | |||
| GOG-LAP2 | Other Identifier | Gynecologic Oncology Group | |
| GOG-LAP2 | Other Identifier | CTEP | |
| U10CA027469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo vaginal hysterectomy and BSO via laparoscopy. |
|
| Arm II | Active Comparator | Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Surgery | Procedure | Undergo vaginal hysterectomy and BSO via laparoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of disease-free interval | The usual logrank test or a proportional hazards model will be used to assess the equality of the hazard rates between the surgical procedures. | Up to 5 years |
| Frequency of aborting LAVH in order to perform an TAH/BSO | Up to 5 years | |
| 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 | |
| Length of hospitalization following surgery | A proportional odds model will be used to estimate the treatment difference while adjusting for potential confounding factors. | From the date of surgery to the date of discharge, assessed up to 5 years |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Walker | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecologic Oncology Group | Philadelphia | Pennsylvania | 19103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29037481 | Derived | 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. |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Therapeutic Conventional Surgery | Procedure | Undergo total abdominal hysterectomy and BSO via conventional laparotomy |
|
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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