18 and older, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pelvic Recurrence Rate at 3 YearsPrimary· 3 years
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
Group
Value
95% CI
Radical Hysterectomy
2.17
0.84 – 3.50
Simple Hysterectomy
2.52
1.07 – 3.97
Pelvic Relapse-free SurvivalSecondary· 3 years
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.
Group
Value
95% CI
Radical Hysterectomy
97.5
95.9 – 99.1
Simple Hysterectomy
97.8
96.2 – 99.4
Extra-pelvic Relapse-free SurvivalSecondary· 3 years
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.
Group
Value
95% CI
Radical Hysterectomy
99.7
99.1 – 100.0
Simple Hysterectomy
98.1
96.6 – 99.6
Relapse-free SurvivalSecondary· 3 years
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.
Group
Value
95% CI
Radical Hysterectomy
97.8
96.2 – 99.4
Simple Hysterectomy
96.3
94.2 – 98.4
Overall SurvivalSecondary· 3 years
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.
Group
Value
95% CI
Radical Hysterectomy
99.4
98.5 – 100.0
Simple Hysterectomy
99.1
98.0 – 100.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Observed during the follow-up (up to 7 years after 4 weeks of surgery)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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· recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Canadian Cancer Trials Group
Last refreshed: 17 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01658930.