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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017138
Receipt No. R000019874
Scientific Title Phase II trial of dose dense paclitaxel plus carboplatin in advanced or recurrent uterine corpus cancer
Date of disclosure of the study information 2015/04/20
Last modified on 2019/12/31

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Basic information
Public title Phase II trial of dose dense paclitaxel plus carboplatin in advanced or recurrent uterine corpus cancer
Acronym KCOG-G-1301 trial
Scientific Title Phase II trial of dose dense paclitaxel plus carboplatin in advanced or recurrent uterine corpus cancer
Scientific Title:Acronym KCOG-G-1301 trial
Region
Japan

Condition
Condition Advanced or recurrent uterine corpus cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We study the effectiveness and safety of dose dense paclitaxel plus carboplatin in advanced or recurrent uterine corpus cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Paclitaxel 80mg/m2 day1, 8, 15+
Carboplatin AUC 6 day1 every 3 weeks
Interventions/Control_2
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
75 years-old >
Gender Female
Key inclusion criteria 1),2),7);Women 20-75 years of age with histologically confirmed uterine corpus cancer, as endometrioid carcinoma, serous carcinoma, mucinous carcinoma, clear cell carcinoma, squamous cell carcinoma, traditional cell carcinoma, carcinosarcoma, or undifferentiated carcinoma.
A) Patients with FIGO stage III had residual tumor. B) FIGO stage IV. C) Recurrence after first-line radical treatment. D) Recurrence after second line chemotherapy or radiotherapy.
3), 6) No prior therapy, over 6 months after chemotherapy with platinum plus taxane (only one regimen was permitted), or over 3 months chemotherapy after non-platinum and non-taxane chemotherapy.
4)Measurable lesion
5)No bilateral hydronephrosis
8)Performance status (ECOG);0-2
9)laboratory date in two weeks
a) neutrophil; more than 1500/mm3
b) platelet; morethan 100000/mm3
c) hemoglobin; more than 10g/dl
d) total bilirubin; more than 1.5mg/dl
e) serum creatinine; less than1.5mg/dl
f) Ccr calculated by Cockcroft's formula; more than 50ml/min
10) life expectancy of more than 3 months
11) written informed consent
Key exclusion criteria 1)motor or sensory neuropathy with dysfunction
2) alcoholic hypersensitivity
3)bacterial infection to needtreatment
4) myocardial infarction within 6 months
5) unstable angina
6) poor control diabetes
7) active multiple malignancy
8) Interstitial pneumonia, pulmonary fibrosis
9) Paclitaxel or CBDCA is contra-indicated.
10) HBs-Ag(+)
11) Paralytic or mechanical bowel obstruction
12) History of severe drug-induced hypersensitivity syndrome
13) Any other cases who are regarded as inadequate for study enrollment by investigators.

Target sample size 48

Research contact person
Name of lead principal investigator
1st name Kensuke
Middle name
Last name Hori
Organization Kansai Rosai Hospital
Division name obgy
Zip code 6608511
Address 3-1-69 Inabasou, Amagasaki city, Hyogo, Japan
TEL +81-6-6416-1221
Email hori-kensuke@kansaih.johas.go.jp

Public contact
Name of contact person
1st name Kensuke
Middle name
Last name Hori
Organization Kansai Rosai Hospital
Division name obgy
Zip code 660-8511
Address 3-1-69 Inabasou, Amagasaki city, Hyogo, Japan
TEL +81-6-6416-1221
Homepage URL
Email hori-kensuke@kansaih.johas.go.jp

Sponsor
Institute Kansai Clinical Oncology Group
Institute
Department

Funding Source
Organization Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kansai Rosai Hospital
Address 3-1-69, Inabasou, Amagasaki city, Hyogo, Japan
Tel 06-6416-1221
Email hori-kensuke@kansaih.johas.go.jp

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 関西ろうさい病院(兵庫県)、大阪大学(大阪府)、三重大学(三重県)、四国がんセンター(愛媛県)
久留米大学(福岡県)、名古屋市立大学(愛知県)、鳥取大学(鳥取県)、静岡県立がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 20 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 48
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 Main results already published
Date of protocol fixation
2015 Year 04 Month 20 Day
Date of IRB
2015 Year 04 Month 30 Day
Anticipated trial start date
2015 Year 04 Month 20 Day
Last follow-up date
2019 Year 03 Month 17 Day
Date of closure to data entry
2019 Year 03 Month 17 Day
Date trial data considered complete
2019 Year 03 Month 17 Day
Date analysis concluded
2019 Year 03 Month 17 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 14 Day
Last modified on
2019 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019874

Research Plan
Registered date File name
2017/09/04 KCOG-G1303 実施計画書 2.1他.zip

Research case data specifications
Registered date File name
2017/09/04 KCOG1303.xls

Research case data
Registered date File name


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