A RANDOMIZED TRIAL COMPARING RADICAL HYSTERECTOMY AND PELVIC NODE DISSECTION VS SIMPLE HYSTERECTOMY AND PELVIC NODE DISSECTION IN PATIENTS WITH LOW RISK EARLY STAGE CERVICAL CANCER

A RANDOMIZED TRIAL COMPARING RADICAL HYSTERECTOMY AND PELVIC NODE DISSECTION VS SIMPLE HYSTERECTOMY AND PELVIC NODE DISSECTION IN PATIENTS WITH LOW RISK EARLY STAGE CERVICAL CANCER - SHAPE-trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55443

Enrollment

110

Registered

2013-10-29

Start date

2014-12-24

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the cerivx cervical cancer

Interventions

Arm 1 - Radical Hysterectomy (Type 2) This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2 cm of the uterosacral l

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: squamous of adenocarcinoma of the cervix

Exclusion criteria

Exclusion criteria: High risk histology (clear cell, small cell) Stage IA1 Evidence of lymph node metastasis or extra-uterine spead on pelvic MRI Neo-adjuvant chemotherapie Pregnancy Desire to preserve fertility

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: pelvic relapse-free survival. Pelvic Relapse-Free Survival is defined as the date from randomization to the date of first documented reappearance (recurrence) of disease provided that this recurrence is in the pelvis. A pelvic recurrence is defined as a recurrence within the pelvis, below the pelvic brim and inferior to the L4-L5 vertebral level. Pelvic recurrences will include disease recurrence in the vaginal vault, parametrium and pelvic lymph nodes (including the common iliac nodes). In the intent-to-treat analysis, patients found to have more advanced stages of cervical cancer on sentinel node mapping, pelvic node dissection or other intraoperative findings consistent with pelvic disease will be considered to have pelvic disease relapse as of the date of the surgical procedure. These patients will be excluded from the per-protocol analysis.	—

Measure

Time frame

Primary Endpoint: pelvic relapse-free survival. Pelvic Relapse-Free Survival is defined as the date from randomization to the date of first documented reappearance (recurrence) of disease provided that this recurrence is in the pelvis. A pelvic recurrence is defined as a recurrence within the pelvis, below the pelvic brim and inferior to the L4-L5 vertebral level. Pelvic recurrences will include disease recurrence in the vaginal vault, parametrium and pelvic lymph nodes (including the common iliac nodes). In the intent-to-treat analysis, patients found to have more advanced stages of cervical cancer on sentinel node mapping, pelvic node dissection or other intraoperative findings consistent with pelvic disease will be considered to have pelvic disease relapse as of the date of the surgical procedure. These patients will be excluded from the per-protocol analysis.

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Secondary

Measure	Time frame
To compare the two treatment arms with respect to: - Extrapelvic relapse-free survival - Relapse-free survival (any site) - Overall survival - Treatment-related toxicity - Patient Reported Outcomes including global quality of life and measures of sexual health - Cost-effectiveness and cost-utility To observe rates of the following in this patient population: - Sentinel node detection - Parametrial involvement - Involvement of surgical margins - Pelvic node involvement	—

Measure

Time frame

To compare the two treatment arms with respect to: - Extrapelvic relapse-free survival - Relapse-free survival (any site) - Overall survival - Treatment-related toxicity - Patient Reported Outcomes including global quality of life and measures of sexual health - Cost-effectiveness and cost-utility To observe rates of the following in this patient population: - Sentinel node detection - Parametrial involvement - Involvement of surgical margins - Pelvic node involvement

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026