UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007218 |
|---|---|
| Receipt number | R000008492 |
| Scientific Title | Phase I/II study about nedaplatin plus radiation (external beam + intra-cavitary) for local advanced uterine cervical cancer. |
| Date of disclosure of the study information | 2012/02/03 |
| Last modified on | 2016/02/03 10:03:16 |
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Basic information
Public title
Phase I/II study about nedaplatin plus radiation (external beam + intra-cavitary) for local advanced uterine cervical cancer.
Acronym
Nedaplatin in cemoradiation for uterine cervical cancer
Scientific Title
Phase I/II study about nedaplatin plus radiation (external beam + intra-cavitary) for local advanced uterine cervical cancer.
Scientific Title:Acronym
Nedaplatin in cemoradiation for uterine cervical cancer
Region
| Japan |
Condition
Condition
uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform phases I/II of chemoradiation with NDP for local advanced uterine cervial cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
In step 1, MTD (maximum tolerated dose) and RD(recommended dose) of nedaplatin.
Key secondary outcomes
In stap 2, primary endpoint = response rate and secondary endpoints = safety (occurrence frequency of adverse event), progress free survival, and overall survival.
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
| Maneuver |
Interventions/Control_1
Phase I = Nedaplatin 80mg/m2 --> 90mg/m2 --> 100mg/m2
Phase II = recommeded dose (RD)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. histopathological proven uterine cervical carcinoma
2. cT1b-2a with bulky mass (tumor size > 4cm) or cT2b-4a
3. PS: 0-2
4. written informed consent
5. WBC: 4000-12000/mm3, Neu > 2000/mm3, Plt > 100,000/mm3 Hb > 9.0g/dL, Tbil < 1.5mg/dL, GOT/GPT < 76/72, CRE < 1.2
Key exclusion criteria
1. chemotherapy naive
2. pelvic irradiation naive
3. M1 (having distant metastasis)
4. having para-aortic lymph node metastasis
5. having serious coexisting illness
6. having synchronism overlap cancer
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kae Okuma |
Organization
University of Tokyo Hospital
Division name
Department of Radiology
Zip code
Address
Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8667
ookumak-rad@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kae Okuma |
Organization
University of Tokyo Hospital
Division name
Department of Radiology
Zip code
Address
Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8743
Homepage URL
ookumak-rad@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Radiology, University of Tokyo Hospital
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
東京大学医学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
http://www.u-tokyo-rad.jp/comparison/rinsyou1.html
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 03 | Day |
Last modified on
| 2016 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008492
