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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007218
Receipt No. 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

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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
Obsterics 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
Email 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
Email ookumak-rad@h.u-tokyo.ac.jp

Sponsor
Institute Department of Radiology, University of Tokyo Hospital
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008492

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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