Cervical CancerG-LACCNCT06489795
German-funded Laparoscopic Approach to Cervical Cancer
A study testing Laparoscopic or robot-assisted radical/simple hysterectomy and Abdominal radical/simple hysterectomy in people with Cervical Cancer, run by Hannover Medical School at 14 sites in Germany.
Trial summary
The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial. 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Laparoscopic or robot-assisted radical/simple hysterectomy and Abdominal radical/simple hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 14 sitesGermany
- Study dates
- 17 Jul 2024to Jan 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- Patients with FIGO stage IA2, IB1, or IB2 disease (<4 cm)
- 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.
- Performance status of ECOG 0-1
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- Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery
- Patients who have signed an approved Informed Consent
- Patients with a prior malignancy only if > 5 years previous with no evidence of disease
- Females, aged 18 years or older
Who cannot join
- Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix
- Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination
- FIGO stage IB3 - IV
- Patients with a history of pelvic or abdominal radiotherapy
- Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2 cm, or histologically positive lymph nodes
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
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- Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- Patient compliance and geographic proximity that do not allow adequate follow-up
- Women who are pregnant
- Patients with contraindications to surgery
- 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)
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Germany14 sites, 14 recruiting
- Recruiting
Hochtaunus-Clinics Bad Homburg, Department of Gynecology
Bad Homburg, Hesse, 61352
Dominik Denschlag, Prof. Dr., +49 (0) 6172 14 ext. 2580, sekretariat-frauenklinik@hochtaunus-kliniken.de
- Recruiting
Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics
Berlin, 14193
Uwe A. Ulrich, Prof. Dr., +49 (0) 30 8955 ext. 3311, gynaekologie.martin-luther@jsd.de
- Recruiting
Vivantes Auguste-Viktoria-Hospital, Department of Gynecology
Berlin Schöneberg, State of Berlin, 12157
Farnaz Jakubek, +49 (0) 30 130 20 ext. 2402, gyn-ambulanz.avk@vivantes.de
- Recruiting
Hospital Bielefeld - Center, Department of Gynecology
Bielefeld, North Rhine-Westphalia, 33604
Werner Bader, Prof. Dr., +49 (0) 521 581 ext. 3271, frauenklinik@klinikumbielefeld.de
- Recruiting
University Medical Center Düsseldorf, Department of Gynecology and Obstetrics
Düsseldorf, North Rhine-Westphalia, 40225
Tanja Fehm, Prof. Dr., +49 (0) 211 81 ext. 17501, direktion.frauenklinik@med.uni-duesseldorf.de
- Recruiting
University Medical Center Göttingen, Department of Gynecology and Obstetrics
Göttingen, Lower Saxony, 37075
Julia Gallwas, Prof. Dr., +49 (0) 551 396 ext. 2501, direktion.ufk@med.uni-goettingen.de
- Recruiting
University Medical Center Hamburg-Eppendorf, Department of Gynecology
Hamburg, 20246
Jan Dieckmann, Dr., +49 (0) 40 7410 ext. 23800, frauenklinik@uke.de
- Recruiting
Hannover Medical School, Department of Gynecology and Obstetrics
Hanover, Lower Saxony, 30625
Peter Hillemanns, Prof. Dr., +49 (0) 511 532 ext. 6144, frauenklinik@mh-hannover.de
Hermann Hertel, Prof. Dr., +49 (0) 511 532 ext. 9760, frauenklinik@mh-hannover.de
- Recruiting
University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics
Kiel, Schleswig-Holstein, 24105
Ibrahim Alkatout, Prof. Dr., +49 (0) 431 500 ext. 21407, Frauenklinik.Kiel@uksh.de
- Recruiting
Ludwigsburg Hospital, Department of Gynecology and Obstetrics
Ludwigsburg, Baden-Wurttemberg, 71640
Sebastian Berlit, Prof. Dr., +49 (0) 7141 99 ext. 67601
- Recruiting
Hospital Lüneburg, Department of Gynecology
Lüneburg, Lower Saxony, 21339
Peter Dall, Prof. Dr., +49 (0) 4131 77 ext. 2231, frauenklinik@klinikum-lueneburg.de
- Recruiting
University Medical Center Mainz, Department of Obstetrics and Gynecology
Mainz, Rhineland-Palatinate, 55131
Roxana Schwab, PD Dr., +49 (0) 6131 17 ext. 7574, uct-hotline@unimedizin-mainz.de
- Recruiting
University Medical Center Tübingen, Department of Gynecology
Tübingen, Baden-Wurttemberg, 72076
Sara Y. Brucker, Prof. Dr., +49 (0) 7071 29 ext. 80791, frauenklinik@med.uni-tuebingen.de
- Recruiting
Protestant Hospital Wesel, Gynecological Cancer Center
Wesel, North Rhine-Westphalia, 46485
Nicole Sigrist-Uhl, +49 (0) 281 106 ext. 2700, gynaekologie@evkwesel.de
About this study
Official title: A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer
The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial.
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.
Read the detailed description
Eligible patients will be randomly allocated to both treatment arms in a 1:1 ratio. Within an accrual period of 4 years, 378 patients will be included per arm (756 in total) across all sites. The Follow-up period after surgery will take a minimum of 5 years.
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
- Cervical Cancer
- Being tested
- Laparoscopic or robot-assisted radical/simple hysterectomy, Abdominal radical/simple hysterectomy
- Keywords
- cervical cancer FIGO stage IA2, cervical cancer FIGO stage IB1, cervical cancer FIGO stage IB2, laparoscopic or robot-assisted radical/simple hysterectomy, abdominal radical/simple hysterectomy, simple hysterectomy in the case of SHAPE criteria
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic or robot-assisted radical/simple hysterectomyProcedure or surgery
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 hysterectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy | Experimental | In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical/simple hysterectomy. Receives: Procedure: Laparoscopic or robot-assisted radical/simple hysterectomy |
| Control intervention: Abdominal radical/simple hysterectomy | Other | In the control arm, abdominal radical/simple hysterectomy (ARH) will be used as standard therapy. Receives: Procedure: Abdominal radical/simple hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival (DFS) is defined as the time from randomization to disease recurrence or death from any course (whichever occurs first). The date of disease recurrence is defined as the date of biopsy.
Measured: up to year 5
Secondary outcomes (13)
Overall survival
Overall survival (OS) is defined as the time from randomization to death from any cause.
Measured: up to year 5
Disease recurrence
The date of recurrence of disease is defined as the date of biopsy. A suspicion of disease recurrence (clinical or by imaging) should be verified by histopathological assessment. Disease recurrence will be assessed and recorded at each follow-up visit starting 6 months post-surgery.
Measured: up to year 5 starting 6 months post-surgery
Health Related Quality of Life (HRQoL): Core questionnaire
Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-30)
Measured: up to year 5
Health Related Quality of Life (HRQoL): Cervical cancer questionnaire
Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EORTC QLQ Cervical Cancer Module (EORTC QLQ-CX24)
Measured: up to year 5
Health Related Quality of Life (HRQoL): General health status
Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EuroQoL EQ-5D-3L
Measured: up to year 5
Health Related Quality of Life (HRQoL): Sexual activity
Health Related Quality of Life (HRQoL) will be assessed by using the validated sexual activity questionnaires (SAQ).
Measured: up to year 5
Lymphatic side effects: Investigator assessment
Lymphatic side effects will be assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE 3.0)
Measured: up to year 5
Lymphatic side effects: Patient assessment
Lymphatic side effects will be assessed by the patient using the Lymphoedema Quality-of-Life (LYMQOL) questionnaire.
Measured: up to year 5
Complications and treatment-associated morbidity
Treatment-related intraoperative complications are recorded on the day of surgery according to Rosenthal's definition.
Treatment-related postoperative complications are recorded from the day of surgery until one year after surgery.
Measured: up to one year after surgery
Serious adverse events
Serious adverse events (SAEs) will be captured from the day of surgery until one year post surgery. Treatment-related SAEs are documented as intra-/postoperative complications according to Outcome 5.
Measured: up to one year after surgery
Health care costs: Cost-effectiveness
Cost-effectiveness will be determined as incremental cost-effectiveness ratios.
Measured: up to year 5
Health care costs: Direct cost assessment
Direct costs will be assessed via internal accounting and billing systems within the hospitals.
Measured: up to year 5
Health care costs: Cost-utility analysis
Quality-adjusted life years (QALY) calculations will be used for a cost-utility analysis.
Measured: up to year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start17 Jul 2024
- Primary completionJul 2033 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, multicenter, open-label, randomized, controlled non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid
- Responsible party
- Principal investigator, Peter Hillemanns, Hannover Medical School
- Investigators
- Peter Hillemanns, Prof. Dr., Principal investigator, Hannover Medical School, Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489795
- Sponsor's protocol ID
- G-LACC
- Acronym
- G-LACC
- Status last verified
- Jan 2025
- First submitted
- 23 Jun 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer
- ClinicalTrials.gov ID
- NCT06489795
- Acronym / sponsor ID
- G-LACC / G-LACC
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer FIGO stage IA2, cervical cancer FIGO stage IB1, cervical cancer FIGO stage IB2, laparoscopic or robot-assisted radical/simple hysterectomy, abdominal radical/simple hysterectomy, simple hysterectomy in the case of SHAPE criteria
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Cancer Aid
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial.
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.
Detailed description
Eligible patients will be randomly allocated to both treatment arms in a 1:1 ratio. Within an accrual period of 4 years, 378 patients will be included per arm (756 in total) across all sites. The Follow-up period after surgery will take a minimum of 5 years.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, multicenter, open-label, randomized, controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy | Experimental | Procedure: Laparoscopic or robot-assisted radical/simple hysterectomyIn the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical/simple hysterectomy. |
| Control intervention: Abdominal radical/simple hysterectomy | Other | Procedure: Abdominal radical/simple hysterectomyIn the control arm, abdominal radical/simple hysterectomy (ARH) will be used as standard therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- Patients with FIGO stage IA2, IB1, or IB2 disease (<4 cm)
- 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.
Key exclusion criteria (11 listed)
- Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix
- Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination
- FIGO stage IB3 - IV
- Patients with a history of pelvic or abdominal radiotherapy
- Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2 cm, or histologically positive lymph nodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic or robot-assisted radical/simple hysterectomyIn 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. | Procedure or surgery | Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy |
| Abdominal radical/simple hysterectomyIn 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. | Procedure or surgery | Control intervention: Abdominal radical/simple hysterectomy |
Primary outcome
Disease-free survival
Time frame: up to year 5
Disease-free survival (DFS) is defined as the time from randomization to disease recurrence or death from any course (whichever occurs first). The date of disease recurrence is defined as the date of biopsy.
13 secondary outcomes
Overall survival
Time frame: up to year 5
Disease recurrence
Time frame: up to year 5 starting 6 months post-surgery
Health Related Quality of Life (HRQoL): Core questionnaire
Time frame: up to year 5
Health Related Quality of Life (HRQoL): Cervical cancer questionnaire
Time frame: up to year 5
Health Related Quality of Life (HRQoL): General health status
Time frame: up to year 5
Health Related Quality of Life (HRQoL): Sexual activity
Time frame: up to year 5
Lymphatic side effects: Investigator assessment
Time frame: up to year 5
Lymphatic side effects: Patient assessment
Time frame: up to year 5
Complications and treatment-associated morbidity
Time frame: up to one year after surgery
Serious adverse events
Time frame: up to one year after surgery
Health care costs: Cost-effectiveness
Time frame: up to year 5
Health care costs: Direct cost assessment
Time frame: up to year 5
Health care costs: Cost-utility analysis
Time frame: up to year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Hillemanns, Prof. Dr. principal investigator
Hannover Medical School, Department of Gynecology and Obstetrics
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic or robot-assisted radical/simple hysterectomy and Abdominal radical/simple hysterectomy in people with Cervical Cancer, run by Hannover Medical School at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Hillemanns, Prof. Dr. (+49 (0) 511 532 ext. 6144, frauenklinik@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: up to year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.