UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000904 |
|---|---|
| Receipt number | R000001091 |
| Scientific Title | Phase II study of radiation therapy for isolated para-aoritc lymph node recurrence in patients with uterine cervical carcinoma |
| Date of disclosure of the study information | 2007/11/22 |
| Last modified on | 2011/12/22 20:02:00 |
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Basic information
Public title
Phase II study of radiation therapy for isolated para-aoritc lymph node recurrence in patients with uterine cervical carcinoma
Acronym
Phase II study of radiation therapy for isolated PALN in UCC
Scientific Title
Phase II study of radiation therapy for isolated para-aoritc lymph node recurrence in patients with uterine cervical carcinoma
Scientific Title:Acronym
Phase II study of radiation therapy for isolated PALN in UCC
Region
| Japan |
Condition
Condition
uterine cervical carcinoma
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of radiatin thearapy for isolated para-aoritic lymph node recurrence in patients with uterine cervical carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-year overall survival
Key secondary outcomes
3-year progression-free survival, acute morbidity, proportion of ptorocl completion, late morbidity
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
| Device,equipment | Maneuver |
Interventions/Control_1
radiation therapy
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
Female
Key inclusion criteria
1) pathological proven carcinoma
29 abdominal para-aoritc lymph node recurrence digagnosed by CT
3) no other recurrent sites than abdominal para-aoritc region
4) 20 <= Age < 80
5) PS: 0-2
6) no prior radiation therapy for adomen
7) adequate bone marrow function, renal function, hepatic function
8) written informed consent
Key exclusion criteria
1) active double carcinoma exept carcinoma in situ
2) severe dementia
3) continous infusion and/or intake of steroids
4) severe complications
5) severe mental disorder
6) inappropriate judged by physicians
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazushige Hayakawa |
Organization
Kitasato University School of Medicine
Division name
Radiology
Zip code
Address
1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuzuru Niibe |
Organization
Kitasato University School of Medicine
Division name
Radiology
Zip code
Address
1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kitasato Gynecologic Radiation Oncology Group: KGROG
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
Hiroshima University, Saitama Cancer Center
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
| 2007 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
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
Terminated
Date of protocol fixation
| 2007 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 22 | Day |
Last modified on
| 2011 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001091
