UMIN-CTR Clinical Trial

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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025884
Receipt No. R000029756
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

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Basic information
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
Japan Asia(except Japan)

Condition uterine carcinosarcoma
Classification by specialty
Hematology and clinical oncology Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

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 objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Primary outcomes progression-free survival
Key secondary outcomes overall survival, response rate, adverse events

Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

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

Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
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
1st name
Middle name
Last name Toshiaki Saito
Organization National Kyushu Cancer Center
Division name Department of Gynecology,
Zip code
Address 3-1-1 Nodame, Minami-ku, Fukuoka city
TEL 092-541-3231

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Harano
Organization National Cancer Center Hospital East
Division name Department of Experimental Therapeutics
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa city
TEL 04-7133-1111
Homepage URL

Institute Japanese Gynecologic Oncology Group

Funding Source
Organization Japanese Gynecologic Oncology Group
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions JGOG加盟施設

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Recruitment status Preinitiation
Date of protocol fixation
2016 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information

Management information
Registered date
2017 Year 01 Month 27 Day
Last modified on
2017 Year 01 Month 27 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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