Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01506856
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2011-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 655}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival(PFS)', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until 510 events are observed or until 3 years from the last patient is randomized to the study'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter'}, {'measure': 'Tumor response (only patients with evaluable disease)', 'timeFrame': 'every 2 cycles [after 2 cycles, after 4 cycles, after 6 cycles, (after 8 cycles)], the time of discontinuation of the protocol treatment and then at least annually during follow-up'}, {'measure': 'Adverse events', 'timeFrame': 'weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter'}, {'measure': 'Treatment completion rate', 'timeFrame': 'After the last cycle of the protocol teatment'}, {'measure': 'Quality of Life (QOL) assessments', 'timeFrame': 'baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment'}, {'measure': 'Cost-utility analysis', 'timeFrame': 'baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epithelial ovarian cancer', 'Fallopian tube cancer', 'peritoneal cancer', 'intraperitoneal therapy', 'Carboplatin', 'Paclitaxel'], 'conditions': ['Epithelial Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '11870167', 'type': 'BACKGROUND', 'citation': 'Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248.'}, {'pmid': '10963636', 'type': 'BACKGROUND', 'citation': 'Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, de Swart CA, Hirsch FR, Lund B, van Houwelingen HC. Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol. 2000 Sep;18(17):3084-92. doi: 10.1200/JCO.2000.18.17.3084.'}, {'pmid': '10793106', 'type': 'BACKGROUND', 'citation': 'Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000 May 3;92(9):699-708. doi: 10.1093/jnci/92.9.699.'}, {'pmid': '12860964', 'type': 'BACKGROUND', 'citation': 'Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. doi: 10.1200/JCO.2003.02.153. Epub 2003 Jul 14.'}, {'pmid': '19767092', 'type': 'BACKGROUND', 'citation': 'Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. doi: 10.1016/S0140-6736(09)61157-0. Epub 2009 Sep 18.'}, {'pmid': '8960474', 'type': 'BACKGROUND', 'citation': "Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603."}, {'pmid': '11181662', 'type': 'BACKGROUND', 'citation': 'Markman M, Bundy BN, Alberts DS, Fowler JM, Clark-Pearson DL, Carson LF, Wadler S, Sickel J. Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol. 2001 Feb 15;19(4):1001-7. doi: 10.1200/JCO.2001.19.4.1001.'}, {'pmid': '16394300', 'type': 'BACKGROUND', 'citation': 'Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.'}, {'pmid': '16095677', 'type': 'BACKGROUND', 'citation': 'Miyagi Y, Fujiwara K, Kigawa J, Itamochi H, Nagao S, Aotani E, Terakawa N, Kohno I; Sankai Gynecology Study Group (SGSG). Intraperitoneal carboplatin infusion may be a pharmacologically more reasonable route than intravenous administration as a systemic chemotherapy. A comparative pharmacokinetic analysis of platinum using a new mathematical model after intraperitoneal vs. intravenous infusion of carboplatin--a Sankai Gynecology Study Group (SGSG) study. Gynecol Oncol. 2005 Dec;99(3):591-6. doi: 10.1016/j.ygyno.2005.06.055. Epub 2005 Aug 10.'}, {'pmid': '17291226', 'type': 'BACKGROUND', 'citation': 'Fujiwara K, Armstrong D, Morgan M, Markman M. Principles and practice of intraperitoneal chemotherapy for ovarian cancer. Int J Gynecol Cancer. 2007 Jan-Feb;17(1):1-20. doi: 10.1111/j.1525-1438.2007.00809.x.'}, {'pmid': '17170036', 'type': 'BACKGROUND', 'citation': 'Demets DL. Futility approaches to interim monitoring by data monitoring committees. Clin Trials. 2006;3(6):522-9. doi: 10.1177/1740774506073115.'}, {'pmid': '17362317', 'type': 'BACKGROUND', 'citation': 'Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007 Mar-Apr;17(2):387-93. doi: 10.1111/j.1525-1438.2007.00794.x.'}, {'pmid': '2681557', 'type': 'BACKGROUND', 'citation': "Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56. doi: 10.1200/JCO.1989.7.11.1748."}], 'seeAlsoLinks': [{'url': 'http://www.jgog.gr.jp/', 'label': 'Japanese Gynecologic Oncology Group'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\nPhase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy).\n\nPhase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary peritoneal cancer.', 'detailedDescription': 'This is a randomized, multicenter international study. Patient are stratified according to Residual tumor diameter(\\[0cm(No residual)\\] vs. \\[0cm\\<residual\\<1cm\\] vs. \\[1cm\\<residual\\<2cm\\] vs. \\[\\>2 cm\\]), FIGO stage(StageII vs. III vs. IV) and institution. Patient randomized to one of the treatment arms described below.\n\nRegimenI(Standard treatment: dd-TCiv therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks\n\nRegimenII(Study treatment: dd-TCip therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks\n\nThe 3-week period (21 days) is 1 cycle. Protocol treatment basically comprises 6 cycles. IDS is allowed to be performed after 3, 4 or 5 cycles of the protocol treatment. In such cases, the protocol treatment must be restarted within 8 weeks after IDS. If IDS is performed, patients can receive up to 3 additional cycles of the protocol treatment after IDS. If interval debulking surgery (IDS) is performed after 3, 4 or 5 cycles, the patients can receive up to 3 additional cycles of the protocol treatment. A total of 6 to 8 cycles will be repeated.\n\nThe analysis of efficacy will be performed on all randomized subjects in accordance with the intention-to-treat (ITT) principle. In order to assess the robustness of the results, the same analyses will be done using all randomized subjects who satisfy the eligibility criteria. The analysis of safety will be performed on all subjects who have received at least one dose of study treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients assumed to have a stageII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis\n2. Patients scheduled to undergo laparotomy\n\n \\*Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.)\n3. ECOG Performance Status: 0-2\n4. Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)\n5. Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery\n6. Lab data and clinical examination: Data within 28 days before the scheduled date of surgery\n\n * Neutrophil count ≧ 1,500 /mm3\n * Platelet count ≧ 100,000 /mm3\n * AST (GOT) ≦ 100 IU/L\n * ALT (GPT) ≦ 100 IU/L\n * Total bilirubin \\< 1.5 mg/dL\n * Serum Creatinine \\< 1.5 mg/dL\n * Electrocardiogram (ECG): Patients with normal ECG, Asymptomatic patients with abnormal ECGs not requiring medical intervention\n * Neuropathy(Both motor and sensory) ≦ Grade1 (CTCAE Version 4.0)\n7. Patients expected to survive longer than 3 months from the start date of the protocol treatment\n8. Patients aged 20 years and older at the time of tentative registration (with no upper age limit)\n9. Patients who provide written informed consent for participation in this trial\n\nExclusion Criteria:\n\n1. Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer\n2. Patients who have received previous chemotherapy or radiation therapy to treat the current disease\n3. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)\n4. Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder\n5. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil\n6. Patients with a pleural effusion requiring continuous drainage\n7. Patients with an active infection requiring antibiotics\n8. Patients who are pregnant, nursing or of child-bearing potential\n9. Patients with evidence upon physical examination of brain tumor and any brain metastases\n10. Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason\n11. Patients with any signs/symptoms of interstitial pneumonia'}, 'identificationModule': {'nctId': 'NCT01506856', 'acronym': 'iPocc', 'briefTitle': 'Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial', 'organization': {'class': 'NETWORK', 'fullName': 'Gynecologic Oncology Trial & Investigation Consortium'}, 'officialTitle': 'A Randomized Phase II/III Trial of Intravenous (IV) Paclitaxel Weekly Plus IV Carboplatin Once Every 3 Weeks Versus IV Paclitaxel Weekly Plus Intraperitoneal (IP) Carboplatin Once Every 3 Weeks in Women With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer', 'orgStudyIdInfo': {'id': 'GOTIC-001/JGOG3019'}, 'secondaryIdInfos': [{'id': 'UMIN000003670', 'type': 'OTHER_GRANT', 'domain': 'University Hospital Medical Information Network = UMIN'}, {'id': 'jRCTs031180141', 'type': 'OTHER_GRANT', 'domain': 'jRCT（Japan Registry of Clinical Trials）'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment: dd-TCiv therapy', 'description': 'Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks', 'interventionNames': ['Drug: Paclitaxel(intravenous) + Carboplatin(intravenous)']}, {'type': 'EXPERIMENTAL', 'label': 'Study treatment: dd-TCip therapy', 'description': 'Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks', 'interventionNames': ['Drug: Paclitaxel(intravenous) + Carboplatin(intraperitoneal)']}], 'interventions': [{'name': 'Paclitaxel(intravenous) + Carboplatin(intravenous)', 'type': 'DRUG', 'otherNames': ['Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)'], 'description': 'Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IV infusion, Day1 A total of 6 to 8 cycles will be repeated.', 'armGroupLabels': ['Standard treatment: dd-TCiv therapy']}, {'name': 'Paclitaxel(intravenous) + Carboplatin(intraperitoneal)', 'type': 'DRUG', 'otherNames': ['Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)'], 'description': 'Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IP injection, Day1 A total of 6 to 8 cycles will be repeated.', 'armGroupLabels': ['Study treatment: dd-TCip therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Pa 15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '102', 'city': 'Hong Kong', 'state': 'High West', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '464-0021', 'city': 'Chikusa', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Cancer Center Hospital', 'geoPoint': {'lat': 35.16311, 'lon': 136.92853}}, {'zip': 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