Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT03562533
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2018-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer
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': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'C041277', 'term': '1-dodecylpyridoxal'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C053518', 'term': 'CP protocol'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 432}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '36 months', 'description': 'OS was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '3years', 'description': 'PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria.'}, {'measure': 'Incidence of Treatment-Related Adverse Events', 'timeFrame': '36 months', 'description': 'Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0.'}, {'measure': 'Response rate', 'timeFrame': '36 months', 'description': 'Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) by Modified RECIST until progression reported. Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31912673', 'type': 'DERIVED', 'citation': 'Park SJ, Kim J, Kim HS, Lee JW, Chang HK, Lee KH, Kim DY, Kim S, Chang SJ, Han SS, Park SY, Shim SH. Real world effectiveness and safety of pegylated liposomal doxorubicin in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer: a Korean multicenter retrospective cohort study. J Gynecol Oncol. 2020 Mar;31(2):e15. doi: 10.3802/jgo.2020.31.e15. Epub 2019 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective multicenter study aimed to evaluate the effectiveness of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with carboplatin and paclitaxel (CP) in patients who had disease progression longer than 6 months after first-line platinum+taxane chemotherapy for ovarian cancer in real world clinical practice.', 'detailedDescription': "Worldwide, ovarian cancer is the sixth most common cancer and the seventh most common cause of cancer deaths in women. At the time of presentation, approximately 70% of women have advanced disease. Despite standard treatment of initial debulking surgery followed by chemotherapy in advanced ovarian cancer, most patients relapse after achieving a complete clinical response. Disease that responds to first-line therapy but relapses after 6 months after completion of initial platinum-based therapy is considered platinum sensitive (PS). Chemotherapy re-treatment is an important aspect in the overall management of patients with PS relapsed or recurrent ovarian cancer (ROC). Platinum is a backbone of treatment, and carboplatin and paclitaxel (CP) have emerged as standard in the first-line setting and been rechallenged in patients with platinum-sensitive ROC. A pooled analysis of three phase III trials from the AGO-OVAR and International Collaborative Ovarian Neoplasm collaborators demonstrated significant improvements in progression-free survival (PFS; hazard ratio \\[HR\\], 0.76; 95% confidence interval \\[CI\\], 0.66 to 0.89; P = .0004) and overall survival (OS; HR, 0.82; 95% CI, 0.69 to 0.97; P = .02) in patients with PS ROC treated with platinum-paclitaxel versus conventional platinum based therapies, mainly carboplatin monotherapy.\n\nHowever, rechallenge with CP has been limited by the risk of cumulative peripheral neuropathy. In addition, grade 2 alopecia (complete hair loss), another ill-tolerated adverse effect for patients facing the distress of relapse, occurs in more than 80% of patients. In order to improve the patient's tolerance on the treatment in this setting, other carboplatin-based combinations, such as gemcitabine and carboplatin, have been explored. This combination significantly improved PFS versus carboplatin alone in phase III trial (HR, 0.72; 95%CI, 0.58 to 0.90; P= .0031). however, OS was not significantly improved (HR, 0.96; 95% CI, 0.75 to 1.23; P = .735); the trial was not powered to detect a survival difference. Grade 3 to 4 hematologic toxicities were significantly more frequent in the combination arm. Thus, a need for other carboplatin combinations remains in PS ROC.\n\nPegylated liposomal doxorubicin (PLD) is an active drug in ROC as the efficacy has been demonstrated in CALYPSO trial.\n\nCAYPSO is a large randomized phase III showing the noninferiority of the combination of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with CP in patients with PS ROC. In this trial, PFS for the CD arm was statistically superior to the CP arm (hazard ratio, 0.821; 95% CI, 0.72 to 0.94; P = .005); median PFS was 11.3 versus 9.4 months, respectively. Overall severe nonhematologic toxicity (36.8% v 28.4%; P = .01) leading to early discontinuation (15% v 6%; P = .001) occurred more frequently in the CP arm. More frequent grade 2 or greater alopecia (83.6% v 7%), hypersensitivity reactions (18.8% v 5.6%), and sensory neuropathy (26.9% v 4.9%) were observed in the CP arm; more hand-foot syndrome (grade 2 to 3, 12.0% v 2.2%), nausea (35.2% v 24.2%), and mucositis (grade 2-3, 13.9% v 7%) in the CD arm.\n\nMoreover, recent subgroup analysis of CALYPSO trial had reported that CD had a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC (patients with a treatment-free interval of \\>6 and ≤12 months). The hazard ratio for PFS was 0.73 (95% CI: 0.58-0.90; P = 0.004 for superiority) in favor of CD.\n\nOn the basis of the results of CALYPSO trial, Korea Food \\& Drug Administration (KFDA) has approved and reimbursed the use of PLD in patients with PS ROC since August 2014. From then, approximately 700 patients with PS ROC have been treated with PLD in Korea.\n\nThe majority of patients enrolled in CALYPSO have 1 prior treatment, however, CD has been used in diverse setting of ROC in Korea. Therefore, the effectiveness and safety of the PLD combination should be still evaluated in the real clinical practice in Korea. To fulfill the gap of knowledge between clinical trials and actual clinical practice, we perform a multicenter, retrospective, observational study of CD therapy in the second line setting of PS ROC."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A histologically confirmed diagnosis of epithelial ovarian, tubal, and primary peritoneal cancer, and recurred \\>6 months after first-line platinum-based chemotherapy regimen', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous taxane therapy was required.\n* Recurred \\>6 months after surgery and first-line platinum-based chemotherapy regimen\n* Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) or CA-125 assessable disease according to Gynecologic Cancer InterGroup (GCIG) criteria or histologic proven diagnosis\n* Eastern Cooperative Oncology Group performance status of ≤ 2\n\nExclusion Criteria:\n\n* Had ovarian tumors of low malignant potential (borderline tumors); nonepithelial or mixed epithelial/nonepithelial tumors (eg, mixed Mullerian tumors)\n* Had received prior radiotherapy; or, had a previous diagnosis of malignancy within the past 5 years.\n* Had bowel obstruction or presence of symptomatic brain metastases\n* Patients with severe active infection\n* Had history of severe hypersensitivity reactions to compounds chemically related to study products.'}, 'identificationModule': {'nctId': 'NCT03562533', 'briefTitle': 'Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Comparison of Real-World Effectiveness of Pegylated Liposomal Doxorubicin Versus Paclitaxel in Platinum- Sensitive Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': 'KUH1040075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pegylated liposomal doxorubicin + carboplatin', 'description': 'carboplatin area under the curve \\[AUC\\] 5 plus pegylated liposomal doxorubicin (PLD) 30 mg/m2 every 4 weeks', 'interventionNames': ['Drug: pegylated liposomal doxorubicin (PLD) + carboplatin (CD)']}, {'label': 'paclitaxel + carboplatin', 'description': 'carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks', 'interventionNames': ['Drug: carboplatin + paclitaxel (CP)']}], 'interventions': [{'name': 'pegylated liposomal doxorubicin (PLD) + carboplatin (CD)', 'type': 'DRUG', 'description': 'carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles', 'armGroupLabels': ['pegylated liposomal doxorubicin + carboplatin']}, {'name': 'carboplatin + paclitaxel (CP)', 'type': 'DRUG', 'description': 'carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles', 'armGroupLabels': ['paclitaxel + carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seung Hyuk Shim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, {'name': 'Ajou University', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}