UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017231 |
|---|---|
| Receipt number | R000007884 |
| Scientific Title | Postoperative concurrent chemoradiotherapy with paclitaxel/carboplatin chemotherapy in patients with high risk early stage cervical cancer. |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2018/11/22 08:03:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Postoperative concurrent chemoradiotherapy with paclitaxel/carboplatin chemotherapy in patients with high risk early stage cervical cancer.
Acronym
Postoperative CCRT using paclitaxel/carboplatin in patients with high risk early stage cervical cancer.
Scientific Title
Postoperative concurrent chemoradiotherapy with paclitaxel/carboplatin chemotherapy in patients with high risk early stage cervical cancer.
Scientific Title:Acronym
Postoperative CCRT using paclitaxel/carboplatin in patients with high risk early stage cervical cancer.
Region
| Japan |
Condition
Condition
Uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a novel postoperative adjuvant radiotherapy in paients with high-risk early-staeg cervical cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly paclitaxel/carboplatin chemoradiotherapy in early stage cervix cancer.
Key secondary outcomes
The efficacy of postoperative paclitaxel/carboplatin chemoradiotherapy in early stage cervix cancer.
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
| Medicine |
Interventions/Control_1
Concurrent weekly carboplatin and paclitaxel combined with adjuvant radiotherapy
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
Early-stage cervical cancer patients with positive pelvic lymph nodes.
Key exclusion criteria
Early-stage cervical cancer patients without pelvic lymph nodes metastasis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi KImura |
Organization
Osaka University Hospital
Division name
Dept of Obstetrics and Gynecology.
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
06-6879-3351
tadashi@gyne.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Mabuchi |
Organization
Osaka University Hospital
Division name
Dept of Obstetrics and Gynecology.
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
06-6879-3351
Homepage URL
smabuchi@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital. Dept of Obstetrics and Gynecology.
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
| 2015 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 09 | Month | 30 | 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
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2018 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007884
