UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000025884|
|Scientific Title||Randomized phase II/III trial comparing dose-dense Paclitaxel and Carboplatin (TC) therapy and conventional triweekly TC therapy for newly diagnosed or recurrent uterine carcinosarcoma|
|Date of disclosure of the study information||2017/01/28|
|Last modified on||2017/01/27|
|Public title||Randomized phase II/III trial comparing dose-dense Paclitaxel and Carboplatin (TC) therapy and conventional triweekly TC therapy for newly diagnosed or recurrent uterine carcinosarcoma
|Acronym||Uterine carcinosarcoma dose-dense TC|
|Scientific Title||Randomized phase II/III trial comparing dose-dense Paclitaxel and Carboplatin (TC) therapy and conventional triweekly TC therapy for newly diagnosed or recurrent uterine carcinosarcoma
|Scientific Title:Acronym||Uterine carcinosarcoma dose-dense TC|
|Classification by specialty||
|Classification by malignancy||Malignancy|
|Narrative objectives1||To test the hypothesis that treatment with dose-dense TC chemotherapy is superior to treatment with conventional triweekly TC treatment in patients with stage I-IV and chemotherapy-naive recurrent uterine carcinosarcoma with respect to the progression-free survival.
|Basic objectives -Others|
|Developmental phase||Phase II,III|
|Primary outcomes||progression-free survival|
|Key secondary outcomes||overall survival, response rate, adverse events|
|Blinding||Open -no one is blinded|
|Institution consideration||Institution is not considered as adjustment factor.|
|No. of arms||2|
|Purpose of intervention||Treatment|
|Type of intervention||
|Interventions/Control_1||triweekly administration of paclitaxel 175mg/m2 and carboplatin AUC6 for 6 cycles|
|Interventions/Control_2||weekly administration of paclitaxel 80mg/m2 every week and triweekly administration of carboplatin AUC6 for 6 cycles|
|Key inclusion criteria||1) Patients who have been diagnosed with FIGO Stage I-IV uterine carcinosarcoma by histopathology of isolated tissues, and patients with recurrent uterine carcinosarcoma who have been confirmed to have distant metastasis at the first onset. Patients who have not undergone hysterectomy are also included in this study if the patients have been diagnosed with uterine carcinosarcoma by biopsy or curettage specimens.
2) Patients who have not undergone chemotherapy before radiotherapy. The period from the completion of radiotherapy to the beginning of protocol treatment should be at least 4 weeks.
3) Patients with ECOG performance status of 0-2
4) Patients who have undergone surgery within 8 weeks before adjuvant treatment.
5) 20 years of age and older (at registration)
6) Patients must have normal hematologic, renal and hepatic function:
Granulocytes >=1500/mcl, platelets >=75000/mcl and hemoglobin >=10 g/dL
Creatinine <=1.5x institutional normal
Bilirubin <=1.5x institutional normal
AST and ALP <=3x institutional normal
Neuronal function: </=Grage 1 of neuropathy (motor, sense) (CTCAE ver. 4).
7) Patients who have provided written informed consent for the participation in this study.
|Key exclusion criteria||1) Patients with infectious disease requiring antimicrobial agent.
2) Patients who have undergone chenotherapy for the primary disease.
3) Patients with a history of other invasive malignancies, with the exception of intraepithelial carcinoma of the uterine cervix, non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocoltherapy.
4) Patients with serious complication (e.g. heart disease, uncontrollable diabetes mellitus, malignant hypertension, bleeding tendency).
5) Patients with active multiple cancers.
6) Patients with pneumonitis or pulmonary fibrosis.
7) Patients with fluid retention requiring treatment.
8) Patients with repeated gastrointestinal bleeding requiring blood products.
9) Patients with a history of unstable angina or myocardial infarction within 6 months before registration, or with complicated severe arrhythmia requiring treatment. However, patients with abnormal cardiac conduction system (e.g. fascicular block, bundle branch block) who have been stable for 6 months before registration is not excluded.
10) Patients who have a contraindication to paclitaxel and carboplatin.
11) Patients with intestinal paralysis or ileus.
12) Patients with a history of severe drug hypersensitivity or allergy.
13) Patients who have been judged to be inappropriate for this study by the investigator
|Target sample size||400|
|Research contact person|
|Name of lead principal investigator||
|Organization||National Kyushu Cancer Center|
|Division name||Department of Gynecology,|
|Address||3-1-1 Nodame, Minami-ku, Fukuoka city|
|Name of contact person||
|Organization||National Cancer Center Hospital East|
|Division name||Department of Experimental Therapeutics|
|Address||6-5-1 Kashiwanoha, Kashiwa city|
|Institute||Japanese Gynecologic Oncology Group|
|Organization||Japanese Gynecologic Oncology Group|
|Category of Funding Organization||Non profit foundation|
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|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
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|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
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|Date of the first journal publication of results|
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|Date of protocol fixation||
|Date of IRB|
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|Last follow-up date|
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|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
|Registered date||File name|
|Research case data|
|Registered date||File name|