Trial Outcomes & Findings for Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer (NCT NCT01658930)
NCT ID: NCT01658930
Last Updated: 2024-12-17
Results Overview
Pelvic recurrence rate at 3 years was estimated by 1-the Kaplan-Meier estimate for the probability of pelvic relapse free survival (PRFS) at 3 years. PRFS was defined as the time from randomization to the time when a recurrence within the pelvic field was first documented. Patients who had a relapse outside of the pelvic field documented or died before the documentation of a pelvic relapse were censored at the time of first documented extra-pelvic relapse or death. The pelvic relapse free survival of patients who were alive without any relapse at the time of final analysis was censored at the last known alive.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
700 participants
Primary outcome timeframe
3 years
Results posted on
2024-12-17
Participant Flow
Participant milestones
| Measure |
Radical Hysterectomy
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
|---|---|---|
|
Overall Study
STARTED
|
350
|
350
|
|
Overall Study
COMPLETED
|
350
|
350
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer
Baseline characteristics by cohort
| Measure |
Radical Hysterectomy
n=350 Participants
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
n=350 Participants
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
Total
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
42 years
n=7 Participants
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
350 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
261 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
525 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
92 participants
n=5 Participants
|
94 participants
n=7 Participants
|
186 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
53 participants
n=5 Participants
|
57 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
China
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
49 participants
n=5 Participants
|
53 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
France
|
64 participants
n=5 Participants
|
58 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=5 Participants
|
27 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: All patients randomized.
Pelvic recurrence rate at 3 years was estimated by 1-the Kaplan-Meier estimate for the probability of pelvic relapse free survival (PRFS) at 3 years. PRFS was defined as the time from randomization to the time when a recurrence within the pelvic field was first documented. Patients who had a relapse outside of the pelvic field documented or died before the documentation of a pelvic relapse were censored at the time of first documented extra-pelvic relapse or death. The pelvic relapse free survival of patients who were alive without any relapse at the time of final analysis was censored at the last known alive.
Outcome measures
| Measure |
Radical Hysterectomy
n=350 Participants
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
n=350 Participants
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
|---|---|---|
|
Pelvic Recurrence Rate at 3 Years
|
2.17 percentage of participants
Interval 0.84 to 3.5
|
2.52 percentage of participants
Interval 1.07 to 3.97
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All patients randomized.
It was defined as the time from randomization to the time when a recurrence within the pelvic field was first documented. Patients who had a relapse outside of the pelvic field documented or died before the documentation of a pelvic relapse were censored at the time of first documented extra-pelvic relapse or death. The pelvic relapse free survival of patients who were alive without any relapse at the time of final analysis was censored at the last known alive. 3 year pelvic relapse-free survival was estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Radical Hysterectomy
n=350 Participants
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
n=350 Participants
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
|---|---|---|
|
Pelvic Relapse-free Survival
|
97.5 percentage of participants
Interval 95.9 to 99.1
|
97.8 percentage of participants
Interval 96.2 to 99.4
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All patients randomized.
It was defined as the time from randomization to the documented reappearance of disease provided that this recurrence is outside of pelvic. Patients who relapsed in pelvic field were censored at the time of first documented pelvic relapse. Patients who died before any relapse or alive without recurrence were censored at the date of death or last known alive date. 3 year extra-pelvic relapse-free survival was estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Radical Hysterectomy
n=350 Participants
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
n=350 Participants
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
|---|---|---|
|
Extra-pelvic Relapse-free Survival
|
99.7 percentage of participants
Interval 99.1 to 100.0
|
98.1 percentage of participants
Interval 96.6 to 99.6
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All patients randomized.
It was defined as the time from randomization to the first time when either a pelvic or extra-pelvic recurrence was documented. Patients who died before any recurrence or alive without recurrence were censored at the date of death or last known alive date. 3 year relapse-free survival was estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Radical Hysterectomy
n=350 Participants
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
n=350 Participants
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
|---|---|---|
|
Relapse-free Survival
|
97.8 percentage of participants
Interval 96.2 to 99.4
|
96.3 percentage of participants
Interval 94.2 to 98.4
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All patients randomized.
It was defined as the time from randomization until death from any cause. The living patients were censored at the date of last known alive. 3 year overall survival was estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Radical Hysterectomy
n=350 Participants
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
n=350 Participants
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
|---|---|---|
|
Overall Survival
|
99.4 percentage of participants
Interval 98.5 to 100.0
|
99.1 percentage of participants
Interval 98.0 to 100.0
|
Adverse Events
Radical Hysterectomy
Serious events: 0 serious events
Other events: 208 other events
Deaths: 7 deaths
Simple Hysterectomy
Serious events: 0 serious events
Other events: 181 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radical Hysterectomy
n=344 participants at risk
Radical Hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
|
Simple Hysterectomy
n=338 participants at risk
Simple hysterectomy + pelvic lymph node dissection: This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
13.7%
47/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
10.7%
36/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Gastrointestinal disorders
Constipation
|
5.5%
19/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
3.8%
13/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
General disorders
Fatigue
|
8.1%
28/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
5.6%
19/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Nervous system disorders
Paresthesia
|
6.4%
22/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
5.0%
17/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
13/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
6.2%
21/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Renal and urinary disorders
Urinary incontinence
|
11.0%
38/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
4.7%
16/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Renal and urinary disorders
Urinary retention
|
9.9%
34/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
0.59%
2/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.5%
19/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
6.2%
21/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.9%
17/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
6.8%
23/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Vascular disorders
Lymphedema
|
10.5%
36/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
10.4%
35/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
|
Vascular disorders
Hot flashes
|
5.8%
20/344 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
4.1%
14/338 • Observed during the follow-up (up to 7 years after 4 weeks of surgery).
Only adverse events related to surgery were collected from patients who had the surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place