UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031670 |
|---|---|
| Receipt number | R000036171 |
| Scientific Title | A prospective cohort study of neoadjuvant chemotherapy using carboplatin and dose dense paclitaxel for locally advanced cervical cancer |
| Date of disclosure of the study information | 2018/03/12 |
| Last modified on | 2018/03/11 13:20:48 |
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Basic information
Public title
A prospective cohort study of neoadjuvant chemotherapy using carboplatin and dose dense paclitaxel for locally advanced cervical cancer
Acronym
CC-NAC
Scientific Title
A prospective cohort study of neoadjuvant chemotherapy using carboplatin and dose dense paclitaxel for locally advanced cervical cancer
Scientific Title:Acronym
CC-NAC
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of neoadjuvant chemotherapy using dose dense TC therapy for patients with locally advanced cervical cancer.
To investigate the pathological mapping of residual tumor after nepoadjuvant chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
2-year progression free survival rate
Key secondary outcomes
Response rate
Pathological complete response rate
2-year overall survival
Toxicity
Site of recurrence
Completion rate of neoadjuvant chemotherapy
Pathological mapping of residual tumor
Imaging findings of residual tumor
Base
Study type
Interventional
Study design
Basic design
expanded access
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
dose dense TC therapy (Carboplatin AUC =6 Day1 + Paclitaxel 80mg/m2 Day1, 8, 15) 3 weeks interval
3 cycles before surgery
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. Pathologically confirmed cervical cancer.
2. FIGO stage Ib2, IIa2, IIb
3. ECOG PS =0 to 2
4. Patients with adequate function of principal organs.
5. Patients expected to live more than 3 months.
6. Patients older than 20 years.
7. Patients with informed consent.
Key exclusion criteria
1. Patients with previous radiation therapy.
2. Any active double cancers.
3. Patients with any serious complications.
4. Patients with hypersensitivity to castor ail.
5. Patients with hypersensitivity to alcohol.
6. Carrier of HBV or HCV.
7. Patients with active infection which needs antibiotics.
8. Patients with interstitial pneumonia.
9. Pregnant woman.
10. Patients regard to be inadequate for entering this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Nagao |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
Address
13-70 Kitaoji-cho, Akashi-city
TEL
078-929-1151
nagao@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Suzuki |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
Address
13-70 Kitaoji-cho, Akashi-city
TEL
078-929-1151
Homepage URL
kazuhi-suzuki@hyogo-cc.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Cancer Center
Organization
Division
Category of Funding Organization
Local Government
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
| 2018 | Year | 03 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
| 2018 | Year | 03 | Month | 11 | Day |
Last modified on
| 2018 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036171
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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