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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000464
Receipt No. R000000562
Scientific Title Phase 1/2 study of the combination of nedaplatin and ifosfamide in patients with advanced or recurrent cervical cancer
Date of disclosure of the study information 2006/08/11
Last modified on 2012/08/11

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Basic information
Public title Phase 1/2 study of the combination of nedaplatin and ifosfamide in patients with advanced or recurrent cervical cancer
Acronym Phase 1/2 study of the combination of nedaplatin and ifosfamide in patients with advanced or recurrent cervical cancer
Scientific Title Phase 1/2 study of the combination of nedaplatin and ifosfamide in patients with advanced or recurrent cervical cancer
Scientific Title:Acronym Phase 1/2 study of the combination of nedaplatin and ifosfamide in patients with advanced or recurrent cervical cancer
Region
Japan

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

Objectives
Narrative objectives1 To determine the recommended dose of nedaplatin and ifosfamide in patients with advanced or recurrent cervical cancer, and to evaluate the efficacy and safety with this therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Recommended dose
Dose limiting toxicity
Response rate
Key secondary outcomes Time to progression
Overall survaival
Toxicity

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 Combination chemotherapy with nedaplatin and ifosfamide
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) Histologically confirmed uterine cervical cancer. 2) Clinical stage IVb and recurrent disease 3) Disease with measurable lesion according to RECIST. 4) ECOG Performance Status 0-2 5) No prior chemothrapy and radiotherapy. 6) Adequate bone marrow, cardiac, liver, lung, kidney functions. a) WBC> 3,000/mm3, b) Platelets > 100,000/mm3, c) T-Bil< 1.5 mg/dl, d) Cr< normal upper limits, e) BUN< normal upper limits, f) ECG normal. g) Expected survival more than 3months. h) Fully written informed consent.
Key exclusion criteria 1) Severe complications: a) infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis, b) massive pleural effusion or ascites, c) uncontrollable diabetes mellitus, d) other complications which suffer from progressing study. 2) Co-existence of active other malignancies. 3) Whom the investigator think unappropriate as a candidate.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Mitsuhashi
Organization Graduate School of Medicine, Chiba University
Division name Reproductive Medicine
Zip code
Address 1-8-1 Inohana chuoku, chiba 260-8670, japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Chiba University
Division name Reproductive Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2006 Year 08 Month 11 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 Terminated
Date of protocol fixation
2006 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 08 Month 07 Day
Last modified on
2012 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000562

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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