Last reviewed · How we verify

NCT01658930: SHAPE

Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer

Completed NA Results posted Last updated 17 December 2024
What this trial tests

NA trial testing Radical Hysterectomy + pelvic lymph node dissection in Cervical Cancer in 700 participants. Completed in 4 November 2024.

Timeline
10 December 2012
Primary endpoint
11 March 2023
4 November 2024

Quick facts

Lead sponsorCanadian Cancer Trials Group
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment700
Start date10 December 2012
Primary completion11 March 2023
Estimated completion4 November 2024
Sites87 locations across France, Netherlands, Russia, Belgium, Austria, Ireland, United Kingdom, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Canadian Cancer Trials Group — full company profile →

Who can join

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 Years Primary · 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

GroupValue95% CI
Radical Hysterectomy2.170.84 – 3.50
Simple Hysterectomy2.521.07 – 3.97
Pelvic Relapse-free Survival Secondary · 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.

GroupValue95% CI
Radical Hysterectomy97.595.9 – 99.1
Simple Hysterectomy97.896.2 – 99.4
Extra-pelvic Relapse-free Survival Secondary · 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.

GroupValue95% CI
Radical Hysterectomy99.799.1 – 100.0
Simple Hysterectomy98.196.6 – 99.6
Relapse-free Survival Secondary · 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.

GroupValue95% CI
Radical Hysterectomy97.896.2 – 99.4
Simple Hysterectomy96.394.2 – 98.4
Overall Survival Secondary · 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.

GroupValue95% CI
Radical Hysterectomy99.498.5 – 100.0
Simple Hysterectomy99.198.0 – 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.

Radical Hysterectomy
Serious: 0/344 (0%)
Deaths: 7/344
Simple Hysterectomy
Serious: 0/338 (0%)
Deaths: 7/338
Other adverse events (11 terms — click to expand)

ReactionSystemRadical HysterectomySimple Hysterectomy
Abdominal painGastrointestinal disorders
Urinary incontinenceRenal and urinary disorders
LymphedemaVascular disorders
Urinary retentionRenal and urinary disorders
FatigueGeneral disorders
Pelvic painReproductive system and breast disorders
ParesthesiaNervous system disorders
Peripheral sensory neuropathyNervous system disorders
DyspareuniaReproductive system and breast disorders
Hot flashesVascular disorders
ConstipationGastrointestinal disorders

Data from ClinicalTrials.gov NCT01658930 adverse events section.

Sponsor's own description

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):

  1. Cancer of the cervix uteri: 2021 update.
    Bhatla N, Aoki D, Sharma DN, Sankaranarayanan R. · · 2021 · cited 311× · PMID 34669203 · DOI 10.1002/ijgo.13865
  2. Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.
    Plante M, Kwon JS, Ferguson S, Samouëlian V, et al · · 2024 · cited 179× · PMID 38416430 · DOI 10.1056/nejmoa2308900
  3. ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer.
    Schmeler KM, Pareja R, Lopez Blanco A, Humberto Fregnani J, et al · · 2021 · cited 165× · PMID 34493587 · DOI 10.1136/ijgc-2021-002921
  4. Management and Care of Women With Invasive Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline.
    Chuang LT, Temin S, Camacho R, Dueñas-Gonzalez A, et al · · 2016 · cited 134× · PMID 28717717 · DOI 10.1200/jgo.2016.003954
  5. Surgical treatment of "intermediate risk" lymph node negative cervical cancer patients without adjuvant radiotherapy-A retrospective cohort study and review of the literature.
    Cibula D, Abu-Rustum NR, Fischerova D, Pather S, et al · · 2018 · cited 53× · PMID 30348519 · DOI 10.1016/j.ygyno.2018.10.018
  6. Fertility-sparing management in cervical cancer: balancing oncologic outcomes with reproductive success.
    Willows K, Lennox G, Covens A. · · 2016 · cited 48× · PMID 27795832 · DOI 10.1186/s40661-016-0030-9
  7. Surgery for cervical cancer: consensus & controversies.
    Poddar P, Maheshwari A. · · 2021 · cited 40× · PMID 34854431 · DOI 10.4103/ijmr.ijmr_4240_20
  8. Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.
    Salvo G, Ramirez PT, Leitao MM, Cibula D, et al · · 2022 · cited 34× · PMID 34461074 · DOI 10.1016/j.ajog.2021.08.029

Verify or expand the search:

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

Other Canadian Cancer Trials Group trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing