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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031670
Receipt No. 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

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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
Obsterics 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
Email 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
Email kazuhi-suzuki@hyogo-cc.jp

Sponsor
Institute Hyogo Cancer Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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