UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024368 |
|---|---|
| Receipt number | 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 23:11:17 |
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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
| Obstetrics 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
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
antira@faculty.chbia-u.jp
Sponsor or person
Institute
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028049
