Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT06489795
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2024-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
German-funded Laparoscopic Approach to Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional, multicenter, open-label, randomized, controlled non-inferiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 756}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2034-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2024-06-23', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'up to year 5', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to year 5', 'description': 'Overall survival (OS) is defined as the time from randomization to death from any cause.'}, {'measure': 'Disease recurrence', 'timeFrame': 'up to year 5 starting 6 months post-surgery', 'description': '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.'}, {'measure': 'Health Related Quality of Life (HRQoL): Core questionnaire', 'timeFrame': 'up to year 5', 'description': '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)'}, {'measure': 'Health Related Quality of Life (HRQoL): Cervical cancer questionnaire', 'timeFrame': 'up to year 5', 'description': 'Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EORTC QLQ Cervical Cancer Module (EORTC QLQ-CX24)'}, {'measure': 'Health Related Quality of Life (HRQoL): General health status', 'timeFrame': 'up to year 5', 'description': 'Health Related Quality of Life (HRQoL) will be assessed by using the validated questionnaire EuroQoL EQ-5D-3L'}, {'measure': 'Health Related Quality of Life (HRQoL): Sexual activity', 'timeFrame': 'up to year 5', 'description': 'Health Related Quality of Life (HRQoL) will be assessed by using the validated sexual activity questionnaires (SAQ).'}, {'measure': 'Lymphatic side effects: Investigator assessment', 'timeFrame': 'up to year 5', 'description': 'Lymphatic side effects will be assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE 3.0)'}, {'measure': 'Lymphatic side effects: Patient assessment', 'timeFrame': 'up to year 5', 'description': 'Lymphatic side effects will be assessed by the patient using the Lymphoedema Quality-of-Life (LYMQOL) questionnaire.'}, {'measure': 'Complications and treatment-associated morbidity', 'timeFrame': 'up to one year after surgery', 'description': "Treatment-related intraoperative complications are recorded on the day of surgery according to Rosenthal's definition.\n\nTreatment-related postoperative complications are recorded from the day of surgery until one year after surgery."}, {'measure': 'Serious adverse events', 'timeFrame': 'up to one year after surgery', 'description': '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.'}, {'measure': 'Health care costs: Cost-effectiveness', 'timeFrame': 'up to year 5', 'description': 'Cost-effectiveness will be determined as incremental cost-effectiveness ratios.'}, {'measure': 'Health care costs: Direct cost assessment', 'timeFrame': 'up to year 5', 'description': 'Direct costs will be assessed via internal accounting and billing systems within the hospitals.'}, {'measure': 'Health care costs: Cost-utility analysis', 'timeFrame': 'up to year 5', 'description': 'Quality-adjusted life years (QALY) calculations will be used for a cost-utility analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial.\n\nThe 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.', 'detailedDescription': '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.\n\nIn 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.\n\nIn 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).\n\nDue 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female patients with operable early stage cervical cancer: International Federation of Gynecology and Obstetrics (FIGO) stage IA2 (lymph vascular invasion), IB1, or IB2 and a histologic subtype of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix\n2. Patients with FIGO stage IA2, IB1, or IB2 disease (\\<4 cm)\n3. Patients undergoing radical hysterectomy according either to Type II or III (Piver Classification) or to Type B or C (Querleu and Morrow classification)\n\n OR\n\n 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.\n4. Performance status of ECOG 0-1\n5. Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery\n6. Patients who have signed an approved Informed Consent\n7. Patients with a prior malignancy only if \\> 5 years previous with no evidence of disease\n8. Females, aged 18 years or older\n\nExclusion Criteria:\n\n1. Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix\n2. Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination\n3. FIGO stage IB3 - IV\n4. Patients with a history of pelvic or abdominal radiotherapy\n5. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \\> 2 cm, or histologically positive lymph nodes\n6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)\n7. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position\n8. Patient compliance and geographic proximity that do not allow adequate follow-up\n9. Women who are pregnant\n10. Patients with contraindications to surgery\n11. 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)'}, 'identificationModule': {'nctId': 'NCT06489795', 'acronym': 'G-LACC', 'briefTitle': 'German-funded Laparoscopic Approach to Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer', 'orgStudyIdInfo': {'id': 'G-LACC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy', 'description': 'In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical/simple hysterectomy.', 'interventionNames': ['Procedure: Laparoscopic or robot-assisted radical/simple hysterectomy']}, {'type': 'OTHER', 'label': 'Control intervention: Abdominal radical/simple hysterectomy', 'description': 'In the control arm, abdominal radical/simple hysterectomy (ARH) will be used as standard therapy.', 'interventionNames': ['Procedure: Abdominal radical/simple hysterectomy']}], 'interventions': [{'name': 'Laparoscopic or robot-assisted radical/simple hysterectomy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Experimental intervention: Laparoscopic or robot-assisted radical/simple hysterectomy']}, {'name': 'Abdominal radical/simple hysterectomy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Control intervention: Abdominal radical/simple hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71640', 'city': 'Ludwigsburg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Berlit, Prof. Dr.', 'role': 'CONTACT', 'phone': '+49 (0) 7141 99', 'phoneExt': '67601'}], 'facility': 'Ludwigsburg Hospital, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}, {'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sara Y. Brucker, Prof. Dr.', 'role': 'CONTACT', 'email': 'frauenklinik@med.uni-tuebingen.de', 'phone': '+49 (0) 7071 29', 'phoneExt': '80791'}], 'facility': 'University Medical Center Tübingen, Department of Gynecology', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '61352', 'city': 'Bad Homburg', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dominik Denschlag, Prof. Dr.', 'role': 'CONTACT', 'email': 'sekretariat-frauenklinik@hochtaunus-kliniken.de', 'phone': '+49 (0) 6172 14', 'phoneExt': '2580'}], 'facility': 'Hochtaunus-Clinics Bad Homburg, Department of Gynecology', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Julia Gallwas, Prof. Dr.', 'role': 'CONTACT', 'email': 'direktion.ufk@med.uni-goettingen.de', 'phone': '+49 (0) 551 396', 'phoneExt': '2501'}], 'facility': 'University Medical Center Göttingen, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Hillemanns, Prof. Dr.', 'role': 'CONTACT', 'email': 'frauenklinik@mh-hannover.de', 'phone': '+49 (0) 511 532', 'phoneExt': '6144'}, {'name': 'Hermann Hertel, Prof. Dr.', 'role': 'CONTACT', 'email': 'frauenklinik@mh-hannover.de', 'phone': '+49 (0) 511 532', 'phoneExt': '9760'}], 'facility': 'Hannover Medical School, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '21339', 'city': 'Lüneburg', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Dall, Prof. Dr.', 'role': 'CONTACT', 'email': 'frauenklinik@klinikum-lueneburg.de', 'phone': '+49 (0) 4131 77', 'phoneExt': '2231'}], 'facility': 'Hospital Lüneburg, Department of Gynecology', 'geoPoint': {'lat': 53.2509, 'lon': 10.41409}}, {'zip': '33604', 'city': 'Bielefeld', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Werner Bader, Prof. Dr.', 'role': 'CONTACT', 'email': 'frauenklinik@klinikumbielefeld.de', 'phone': '+49 (0) 521 581', 'phoneExt': '3271'}], 'facility': 'Hospital Bielefeld - Center, Department of Gynecology', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tanja Fehm, Prof. Dr.', 'role': 'CONTACT', 'email': 'direktion.frauenklinik@med.uni-duesseldorf.de', 'phone': '+49 (0) 211 81', 'phoneExt': '17501'}], 'facility': 'University Medical Center Düsseldorf, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '46485', 'city': 'Wesel', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nicole Sigrist-Uhl', 'role': 'CONTACT', 'email': 'gynaekologie@evkwesel.de', 'phone': '+49 (0) 281 106', 'phoneExt': '2700'}], 'facility': 'Protestant Hospital Wesel, Gynecological Cancer Center', 'geoPoint': {'lat': 51.6669, 'lon': 6.62037}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Roxana Schwab, PD Dr.', 'role': 'CONTACT', 'email': 'uct-hotline@unimedizin-mainz.de', 'phone': '+49 (0) 6131 17', 'phoneExt': '7574'}], 'facility': 'University Medical Center Mainz, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ibrahim Alkatout, Prof. Dr.', 'role': 'CONTACT', 'email': 'Frauenklinik.Kiel@uksh.de', 'phone': '+49 (0) 431 500', 'phoneExt': '21407'}], 'facility': 'University Hospital Schleswig-Holstein, Campus Kiel, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '12157', 'city': 'Berlin Schöneberg', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Farnaz Jakubek', 'role': 'CONTACT', 'email': 'gyn-ambulanz.avk@vivantes.de', 'phone': '+49 (0) 30 130 20', 'phoneExt': '2402'}], 'facility': 'Vivantes Auguste-Viktoria-Hospital, Department of Gynecology'}, {'zip': '14193', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Uwe A. Ulrich, Prof. Dr.', 'role': 'CONTACT', 'email': 'gynaekologie.martin-luther@jsd.de', 'phone': '+49 (0) 30 8955', 'phoneExt': '3311'}], 'facility': 'Martin Luther Hospital Berlin, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan Dieckmann, Dr.', 'role': 'CONTACT', 'email': 'frauenklinik@uke.de', 'phone': '+49 (0) 40 7410', 'phoneExt': '23800'}], 'facility': 'University Medical Center Hamburg-Eppendorf, Department of Gynecology', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Peter Hillemanns, Prof. Dr.', 'role': 'CONTACT', 'email': 'frauenklinik@mh-hannover.de', 'phone': '+49 (0) 511 532', 'phoneExt': '6144'}, {'name': 'Oliver Papp', 'role': 'CONTACT', 'email': 'g-lacc.zks@mh-hannover.de', 'phone': '+49 (0) 176 1532', 'phoneExt': '7234'}], 'overallOfficials': [{'name': 'Peter Hillemanns, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School, Department of Gynecology and Obstetrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Aid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med., Director Department of Gynecology and Obstetrics', 'investigatorFullName': 'Peter Hillemanns', 'investigatorAffiliation': 'Hannover Medical School'}}}}