UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective cohort study of neoadjuvant chemotherapy using carboplatin and dose dense paclitaxel for locally advanced cervical cancer
Title of the study (Brief title)	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	Shoji Nagao
Organization	Hyogo Cancer Center
Division name	Gynecologic Oncology
Address	13-70 Kitaoji-cho, Akashi-city
TEL	078-929-1151
Email	nagao@hp.pref.hyogo.jp

Public contact
Name of contact person	Kazuhiro Suzuki
Organization	Hyogo Cancer Center
Division name	Gynecologic Oncology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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