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

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 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


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

Value
https://center6.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