UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004897 |
|---|---|
| Receipt number | R000005807 |
| Scientific Title | Phase l/ll study of adjuvant chemotherapy (TC therapy) after concurrent chemoradiation in cervical cancer with lymphadenopathy |
| Date of disclosure of the study information | 2011/01/19 |
| Last modified on | 2011/01/19 10:05:03 |
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Basic information
Public title
Phase l/ll study of adjuvant chemotherapy (TC therapy) after concurrent chemoradiation in cervical cancer with lymphadenopathy
Acronym
Phase l/ll study of TC therapy after CCRT in cervical cancer
Scientific Title
Phase l/ll study of adjuvant chemotherapy (TC therapy) after concurrent chemoradiation in cervical cancer with lymphadenopathy
Scientific Title:Acronym
Phase l/ll study of TC therapy after CCRT in cervical cancer
Region
| Japan |
Condition
Condition
Cervical cancer with lymphadenopathy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the efficacy and toxicities of CCRT followed by adjuvant chemotherapy with paclitaxel and carboplatin for patients with lymphadenopathy for cervical cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
PFS, tixicity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TC therapy after CCRT
Interventions/Control_2
No adjuvant chemotherapy after CCRT
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with FIGO Stage lB2 - lVA of cervical carcinoma and who had lymphadenopathy (N=1) were eligible. No previous chemotherapy or radiotherapy was allowed. Other eligibility criteria include age under 75 years old, Easttern Cooperation Oncology Group (ECOG) performance status score 0-1, blood cell counts, serum level of bloody urea nitrogen, creatinine, bilirubin within normal ranges, and normal cardiovascular function. The criterion for malignancy on positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) was a pelvis or para-aortic lymph node with short-axis dimension > 1cm or SUV > 3.
Key exclusion criteria
severe complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Furumoto |
Organization
The University of Tokushima Graduate School
Division name
Department of Obstetrics and Gynecology, Institute of Health Biosciences
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, 770-8503 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokushima Graduate School
Division name
department of Obstetrics and Gynecology, Institute of Health Biosciences
Zip code
Address
TEL
Homepage URL
akiko06090111@yahoo.co.jp
Sponsor or person
Institute
The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima Graduate School
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 01 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | 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
| 2011 | Year | 01 | Month | 19 | Day |
Last modified on
| 2011 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005807
