UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Uterine carcinosarcoma dose-dense TC
Region	Japan Asia(except Japan)

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

Objectives
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

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

Base
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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
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	Toshiaki Saito
Organization	National Kyushu Cancer Center
Division name	Department of Gynecology,
Address	3-1-1 Nodame, Minami-ku, Fukuoka city
TEL	092-541-3231
Email	tsaitou@nk-cc.go.jp

Public contact
Name of contact person	Kenichi Harano
Organization	National Cancer Center Hospital East
Division name	Department of Experimental Therapeutics
Address	6-5-1 Kashiwanoha, Kashiwa city
TEL	04-7133-1111
Homepage URL
Email	kharano@east.ncc.go.jp

Sponsor
Institute	Japanese Gynecologic Oncology Group
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	JGOG加盟施設

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029756