Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
756 participants
INTERVENTIONAL
2024-07-17
2034-01-31
Brief Summary
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The main goal of this clinical trial is to evaluate the non-inferiority of minimally invasive radical hysterectomy in contrast to abdominal radical hysterectomy in patients with early-stage cervical cancer. In the case of SHAPE criteria, surgery may also be performed as minimally invasive or abdominal simple hysterectomy. The primary criterion for assessment is disease-free survival (DFS). As secondary outcomes, overall survival (OS), disease recurrence, quality of life, intra-/postoperative complications, and serious adverse events are recorded for assessment.
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Detailed Description
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In the standard arm, radical hysterectomy is performed as per standard technique abdominal radical hysterectomy (Piver type 2 or 3 or Querleu \& Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Surgery includes pelvic lymph node dissection or optional sentinel lymph node biopsy (SNB) according to current guidelines in both arms.
In the experimental arm, radical hysterectomy is performed as per standard conventional 2D/3D laparoscopic or robotic assisted technique (Querleu \& Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. The following protective measures are mandatory for the minimally invasive arm: LEEP/conization prior to randomization or vaginal closure prior to colpotomy. Transcervical manipulators are not permitted. Use of uterus manipulators/ cervical adapter (without transcervical device) is allowed only after LEEP/conization. Meticulous dissection of pelvic (sentinel) lymph nodes including use of endobags and avoiding the dissemination of cancer cells will be implemented (tumor hygiene).
Due to the positive results of the SHAPE trial published at Plante et al. NEJM 2024, in both arms simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor \< 2 cm, \< 10 mm depth of stromal invasion (LEEP/cone) BUT has to be determined BEFORE randomization. Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5 mm vaginal cuff is required to ensure negative margins. Surgery can be performed including removal of the sentinel lymph nodes following the concept of sentinel lymph node biopsy (SNB) and according to the current guidelines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy
In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical/simple hysterectomy.
Laparoscopic or robot-assisted radical/simple hysterectomy
In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical, or in the case of SHAPE criteria, simple hysterectomy.
Control intervention: Abdominal radical/simple hysterectomy
In the control arm, abdominal radical/simple hysterectomy (ARH) will be used as standard therapy.
Abdominal radical/simple hysterectomy
In the control arm, patients with early-stage cervical cancer will be treated by using abdominal radical, or in the case of SHAPE criteria, simple hysterectomy as standard therapy.
Interventions
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Laparoscopic or robot-assisted radical/simple hysterectomy
In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical, or in the case of SHAPE criteria, simple hysterectomy.
Abdominal radical/simple hysterectomy
In the control arm, patients with early-stage cervical cancer will be treated by using abdominal radical, or in the case of SHAPE criteria, simple hysterectomy as standard therapy.
Eligibility Criteria
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Inclusion Criteria
2. Patients with FIGO stage IA2, IB1, or IB2 disease (\<4 cm)
3. Patients undergoing radical hysterectomy according either to Type II or III (Piver Classification) or to Type B or C (Querleu and Morrow classification)
OR
Simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor \< 2cm, \< 10 mm depth of stromal invasion (LEEP/cone). Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5mm vaginal cuff is required to ensure negative margins.
4. Performance status of ECOG 0-1
5. Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery
6. Patients who have signed an approved Informed Consent
7. Patients with a prior malignancy only if \> 5 years previous with no evidence of disease
8. Females, aged 18 years or older
Exclusion Criteria
2. Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination
3. FIGO stage IB3 - IV
4. Patients with a history of pelvic or abdominal radiotherapy
5. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2 cm, or histologically positive lymph nodes
6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
7. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
8. Patient compliance and geographic proximity that do not allow adequate follow-up
9. Women who are pregnant
10. Patients with contraindications to surgery
11. Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity)
18 Years
FEMALE
No
Sponsors
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German Cancer Aid
OTHER
Hannover Medical School
OTHER
Responsible Party
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Peter Hillemanns
Prof. Dr. med., Director Department of Gynecology and Obstetrics
Principal Investigators
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Peter Hillemanns, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School, Department of Gynecology and Obstetrics
Locations
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Ludwigsburg Hospital, Department of Gynecology and Obstetrics
Ludwigsburg, Baden-Wurttemberg, Germany
University Medical Center Tübingen, Department of Gynecology
Tübingen, Baden-Wurttemberg, Germany
Hochtaunus-Clinics Bad Homburg, Department of Gynecology
Bad Homburg, Hesse, Germany
University Medical Center Göttingen, Department of Gynecology and Obstetrics
Göttingen, Lower Saxony, Germany
Hannover Medical School, Department of Gynecology and Obstetrics
Hanover, Lower Saxony, Germany
Hospital Lüneburg, Department of Gynecology
Lüneburg, Lower Saxony, Germany
Hospital Bielefeld - Center, Department of Gynecology
Bielefeld, North Rhine-Westphalia, Germany
University Medical Center Düsseldorf, Department of Gynecology and Obstetrics
Düsseldorf, North Rhine-Westphalia, Germany
Protestant Hospital Wesel, Gynecological Cancer Center
Wesel, North Rhine-Westphalia, Germany
University Medical Center Mainz, Department of Obstetrics and Gynecology
Mainz, Rhineland-Palatinate, Germany
University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics
Kiel, Schleswig-Holstein, Germany
Vivantes Auguste-Viktoria-Hospital, Department of Gynecology
Berlin Schöneberg, State of Berlin, Germany
Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics
Berlin, , Germany
University Medical Center Hamburg-Eppendorf, Department of Gynecology
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Sebastian Berlit, Prof. Dr.
Role: primary
Other Identifiers
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G-LACC
Identifier Type: -
Identifier Source: org_study_id
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