UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000464 |
|---|---|
| Receipt number | 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 23:41:39 |
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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
| Obstetrics 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
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
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
