Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002706
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
1999-11-01
Brief Title:
Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02237 | REGISTRY | None | None |
| CDR0000064513 | None | None | None |
| GOG-LAP2 | OTHER | None | None |
| GOG-LAP2 | OTHER | None | None |