Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-30 @ 5:32 AM
Study NCT ID:
NCT02324595
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2014-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2014-06-17', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative complication rate', 'timeFrame': '30 days', 'description': 'Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery'}], 'secondaryOutcomes': [{'measure': 'Progression Free survival', 'timeFrame': 'one year', 'description': 'time to recurrence'}, {'measure': 'Overall Survival', 'timeFrame': 'One year', 'description': 'time to last follow up/death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ovarian Cancer', 'Laparoscopy', 'Neoadjuvant Chemotherapy', 'Robotic', 'Interval Debulking Surgery'], 'conditions': ['Stage IV Ovarian Carcinoma', 'Effects of Chemotherapy', 'Peritoneal Cavity Cancer']}, 'referencesModule': {'references': [{'pmid': '26529370', 'type': 'DERIVED', 'citation': 'Gueli Alletti S, Bottoni C, Fanfani F, Gallotta V, Chiantera V, Costantini B, Cosentino F, Ercoli A, Scambia G, Fagotti A. Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study. Am J Obstet Gynecol. 2016 Apr;214(4):503.e1-503.e6. doi: 10.1016/j.ajog.2015.10.922. Epub 2015 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Phase II multicentric study', 'detailedDescription': 'The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years,\n* Advanced ovarian cancer submitted to neoadjuvant chemotherapy,\n* Clinical or serological complete/partial response (RECIST; GCIG),\n* PS ≤ 2 (ECOG),\n* Informed consent\n\nExclusion Criteria:\n\n* Borderline and non-epithelial ovarian tumors,\n* Stable/progressive disease,\n* ASA 3-4,\n* Severe cardiopulmonary disease,\n* BMI \\> 40'}, 'identificationModule': {'nctId': 'NCT02324595', 'acronym': 'MISSION', 'briefTitle': 'Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study', 'orgStudyIdInfo': {'id': '10279/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic Interval Debulking Surgery', 'description': 'Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response', 'interventionNames': ['Procedure: Laparoscopic interval debulking surgery']}], 'interventions': [{'name': 'Laparoscopic interval debulking surgery', 'type': 'PROCEDURE', 'otherNames': ['Laparoscopy'], 'description': 'Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm "flexible tip" videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered', 'armGroupLabels': ['Laparoscopic Interval Debulking Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00100', 'city': 'Rome', 'state': 'Rome', 'country': 'Italy', 'facility': 'Catholic University of Sacred Heart Rome,', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'state': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Giovanni Scambia, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of the Sacred Heart'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fagotti, Anna, M.D.', 'class': 'INDIV'}, {'name': 'Fanfani, Francesco, M.D.', 'class': 'INDIV'}, {'name': 'Salvatore Gueli Alletti', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente", 'investigatorFullName': 'Prof. Giovanni Scambia', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}