UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025884 |
|---|---|
| Receipt number | 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 17:50:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Region
| Japan | Asia(except Japan) |
Condition
Condition
uterine carcinosarcoma
Classification by specialty
| Hematology and clinical oncology | Obstetrics 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
| 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
tsaitou@nk-cc.go.jp
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
kharano@east.ncc.go.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029756
