UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017138 |
|---|---|
| Receipt number | 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 11:38:17 |
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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
| Obstetrics 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
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
hori-kensuke@kansaih.johas.go.jp
Sponsor or person
Institute
Kansai Clinical Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
