Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
Study NCT ID:
NCT01363466
Status:
TERMINATED
Last Update Posted:
2011-06-01
First Post:
2011-05-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D018196', 'term': 'Carcinoma, Adenosquamous'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'whyStopped': 'low recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-30', 'studyFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2011-05-30', 'lastUpdatePostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse free survival', 'timeFrame': 'from randomization to relapse or last contact (up to 3 years)', 'description': 'There is a follow-up period of 3 years.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From randomisation to death or last contact (up to 3 years)', 'description': 'There is a follow-up period of 3 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stage IB2 Cervical Cancer', 'Stage II Cervical Cancer', 'Adenocarcinoma', 'Squamous Cell Carcinoma', 'Adenosquamous Carcinoma']}, 'descriptionModule': {'briefSummary': 'GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* operable Stage IB2/II Cervical Cancer\n* adenocarcinoma, squamous cell or adenosquamous carcinoma\n* Patient between 18 and 70 years old\n* No lombo-aortic lymph node invasion at baseline\n* Previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles)\n* Followed by a 15 grays utero-vaginal brachytherapy, eventually combined with a 6th cycle of chemotherapy (cisplatin 40 mg/m2)\n* with a pelvic boost if lymph node or parametrial invasion\n* No macroscopic residual tumor after 6 to 8 weeks after brachytherapy.\n\nExclusion Criteria:\n\n* Other tumor histology (neuro-endocrine)\n* Stage \\> II (FIGO 1995) at baseline\n* Patient with remaining cervical cancer (after sub-total hysterectomy)'}, 'identificationModule': {'nctId': 'NCT01363466', 'briefTitle': 'Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'UNICANCER'}, 'officialTitle': 'Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer', 'orgStudyIdInfo': {'id': 'GYNECO 02/0108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'with hysterectomy', 'interventionNames': ['Procedure: hysterectomy']}, {'type': 'NO_INTERVENTION', 'label': 'without hysterectomy'}], 'interventions': [{'name': 'hysterectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['with hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Clinique Axium', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Polyclinique du Parc Rambot', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '80039', 'city': 'Amiens', 'country': 'France', 'facility': "Clinique Sainte Thérèse de l'enfant Jésus", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'Centre Hospitalier de Beauvais', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '79302', 'city': 'Bressuire', 'country': 'France', 'facility': 'Centre Hospitalier Nord Deux-Sèvres', 'geoPoint': {'lat': 46.84158, 'lon': -0.49042}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21034', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges-François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '77305', 'city': 'Fontainebleau', 'country': 'France', 'facility': 'Centre Hospitalier de Fontainebleau', 'geoPoint': {'lat': 48.40908, 'lon': 2.70177}}, {'zip': '69288', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Hotel-Dieu', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69495', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire - Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Centre Val d'Aurelle-Paul Lamarque", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '29205', 'city': 'Morlaix', 'country': 'France', 'facility': 'Centre hospitalier des Pays de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'zip': '44805', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre René Gauducheau', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': 'Hôpital de la Source', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital des Diaconnesses', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Jean Bernard', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Polyclinique de Courlancy', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35013', 'city': 'Rennes', 'country': 'France', 'facility': 'Clinique Mutualiste de la Sagesse', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35203', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Universitaire Hospitalier- Hôpital Sud', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Régaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Centre Hospitalier Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Philippe MORICE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNICANCER', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Philippe MORICE', 'oldOrganization': 'Institut Gustave Roussy'}}}}