UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009643 |
|---|---|
| Receipt number | R000011312 |
| Scientific Title | Phase II trial of perioperative chemotherapy with cisplatin and dose dense paclitaxel in patients with stage IB2,IIA2 orIIB uterine cervical cancer SGSG014 |
| Date of disclosure of the study information | 2012/12/27 |
| Last modified on | 2019/01/01 15:10:43 |
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Basic information
Public title
Phase II trial of perioperative chemotherapy with
cisplatin and dose dense paclitaxel in patients with
stage IB2,IIA2 orIIB uterine cervical cancer SGSG014
Acronym
Phase II trial of perioperative dose dense TP in patients with
stage IB2,IIA2,IIB uterine cervical cancer (SGSG014)
Scientific Title
Phase II trial of perioperative chemotherapy with
cisplatin and dose dense paclitaxel in patients with
stage IB2,IIA2 orIIB uterine cervical cancer SGSG014
Scientific Title:Acronym
Phase II trial of perioperative dose dense TP in patients with
stage IB2,IIA2,IIB uterine cervical cancer (SGSG014)
Region
| Japan |
Condition
Condition
Cervical cancer patients with clinical stage IB2, IIA, IIB
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of cisplatin and dose dense paclitaxel for cervical cancer patients with clinical stage IB2, IIA, IIb
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year recurrence-free survival rate
Key secondary outcomes
response rate of neoadjuvant dose dense TP, pathologic complete response rate, safety, 2-year overall survival rate, adverse events, site of recurrence
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
cisplatin with dose dense paclitaxel
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Pathologically confirmed uterine crvical cancer
2) Clinical stage Ib2, IIa(primary tumor diameter 4 or more cm),IIb
3) Age from 20 to 70
4) ECOG PS 0-2
5) No prior treatment
6) Normal organ function
7) Written informed consent
Key exclusion criteria
1) Usage of other experimental drugs, phenytoin or flucytosine
2) History of serious drug allergy or hypersensitivity with cisplatin or paclitaxel
3) Massive ascites, ileus
4) Active infection
5) Peripheral neuropathy grade 2-4
6) Unstable angina, myocardinal infarction within 6 months or serious arrthymia
7) Interstitial pneumonia or fibrosis
8) Double cancer
9) No coexisting severe medical conditions such as uncontrollable diabetes mellitus, hypertension or bleeding
10) Pregnancy or lactation
11) Mental disease
12) Continuus usage of steroid
13) Bilateral hydronephrosis
14) Judged as inappropriate to participate this trial by investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamaguchi |
Organization
Hyogo Cancer Center
Division name
Gynecology
Zip code
Address
13-70Kitaoji,Akashi,Hyogo
TEL
078-929-1151
s-yama@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Tanioka |
Organization
Hyogo Cancer Center
Division name
Medical Oncology
Zip code
Address
13-70Kitaoji,Akashi,Hyogo
TEL
078-929-1151
Homepage URL
tanioka@hp.pref.hyogo.jp
Sponsor or person
Institute
Sankai Gynecology Study Group
Institute
Department
Personal name
Funding Source
Organization
Sankai Gynecology Study Group
Organization
Division
Category of Funding Organization
Other
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
SGSGにおいてIRBを通過した病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 27 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
From Aug 15th to Dec 15th 2012, the trial with the same protocol identical to SGSG014 has been conducted. Nine patients enrolled in this trial will be treated as the participants in SGSG014.
Management information
Registered date
| 2012 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011312
