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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002636
Receipt No. 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

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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 Obsterics 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
Email

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
Email tanioka@hp.pref.hyogo.jp

Sponsor
Institute Hyogo Cancer Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003213

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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