UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002636 |
|---|---|
| Receipt number | R000003213 |
| Scientific Title | Phase I/II trial of neoadjuvant chemotherapy with cisplatin and weekly paclitaxel in patients with stage Ib2- IIb uterine cervical cancer |
| Date of disclosure of the study information | 2009/10/25 |
| Last modified on | 2014/10/17 23:25:54 |
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Basic information
Public title
Phase I/II trial of neoadjuvant chemotherapy with cisplatin and weekly paclitaxel in patients with stage Ib2- IIb uterine cervical cancer
Acronym
Neoadjuvant chemotherapy with cisplatin and weekly paclitaxel in patients with cervical cancer
Scientific Title
Phase I/II trial of neoadjuvant chemotherapy with cisplatin and weekly paclitaxel in patients with stage Ib2- IIb uterine cervical cancer
Scientific Title:Acronym
Neoadjuvant chemotherapy with cisplatin and weekly paclitaxel in patients with cervical cancer
Region
| Japan |
Condition
Condition
patients with clinical stage Ib2, IIa(primary tumor diameter ;4 or more cm),IIb uterine cervical cancer
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evluate the recommended dose and the safety of neoadjuvant chemotherapy with CDDP(triweekly)/Paclitaxel(weekly)in a phase I trial and the efficacy and the safety of the neoadjuvant chemotherapy in a phase II trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Dose limiting toxicity(phase I trial)
2-year progression free survival, response rate and safety(phase II trial)
Key secondary outcomes
Safety, 2-year overall survival, 2 year progression free survival(phase I trial)
2-year overall survival, adverse effect,region of reccurence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cisplatin combined with weekly 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
| 75 | 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 75
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
4) Active infection
5) Peripheral neuropathy
6) Unstable angina, myocardinal infarction within 6 months or serious arrthymia
7) Ileus
8) Interstitial pneumonia or fibrosis
9) Double cancer
10)No coexisting severe medical conditions such as uncontrollable diabetes mellitus, hypertension or bleeding
11) Pregnancy or lactation
12) Mental disease
13) Continuus usage of steroid
14) Bilateral hydronephrosis
15) Judged as inappropriate to participate this trial by investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maki Tanioka |
Organization
Hyogo Cancer Center
Division name
Medical oncology
Zip code
Address
Kitaoji 13-70, Akashi, Hyogo,Japan
TEL
078-929-1151
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
Kitaoji 13-70, Akashi, Hyogo,Japan
TEL
078-929-1151
Homepage URL
tanioka@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
兵庫県立がんセンター
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 17 | Day |
Last modified on
| 2014 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003213
