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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024368
Receipt No. R000028049
Scientific Title Concurrent, daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer, Exploratory Trial
Date of disclosure of the study information 2016/10/12
Last modified on 2016/10/11

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Basic information
Public title Concurrent, daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer, Exploratory Trial
Acronym Concurrent, daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer, Exploratory Trial
Scientific Title Concurrent, daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer, Exploratory Trial
Scientific Title:Acronym Concurrent, daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer, Exploratory Trial
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of concurrent daily-low-dose cisplatin-based chemoradiation in patients with cervical cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes Overall survival by histology
Overall survival by age
Adverse effects

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 A total dose of 50 Gy was delivered in 25 daily fractions of2.0 Gy, administered on 5 days a week

CDDP: 8 mg/m2/day weekday x 25
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

Not applicable
Gender Female
Key inclusion criteria 1) Patients with stage IIA to IIIB cervical cancer
according to the International Federation of Gynecologyand Obstetrics,
2) Cervical carcinoma of the non- small cell type (squamous, adenosquamous, and adenocarcinoma), were selected.
3) no previous chemotherapy or radiotherapy
4) ECOG performance status 0-2
5) Leukocyte count of 3,000/mm3 or higher, neutrophil count of 2,000/mm3 or higher, platelet count of 100,000/mm3 or higher, serum creatinine 1.5 mg/dl or less
6)) normal chest radiograph and electrocardiogram.
Key exclusion criteria 1) positive para aortic lymph node swelling
2) severe systemic or uncontrolled disease (uncontrolled diabetes mellitus or hypertension)
3) severe infection that precluded the use of chemotherapy
4) preexisting neuropathy from any cause, pregnancy or lactation
5) mental illness
6) previous or concomitant malignancies
Target sample size 65

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, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Email antira@faculty.chiba-u.jp

Public contact
Name of contact person
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, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Homepage URL
Email antira@faculty.chbia-u.jp

Sponsor
Institute 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
2016 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2003 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2003 Year 01 Month 17 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
2016 Year 10 Month 11 Day
Last modified on
2016 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028049

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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