UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of combination chemotherapy using paclitaxel, carboplatin, and bevacizumab in patients with advanced or recurrent cervical cancer.
Title of the study (Brief title)	CC-Bev
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 of combination chemotherapy using paclitaxel, carboplatin, and bevacizumab (TC+Bev therapy).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Objective response rate
Key secondary outcomes	Overall survival, Progression free survival, Toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Paclitaxel 175mg/m2 Carboplatin AUC =6 Bevacizumab 15mg/kg Q 3 weeks
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. Histologically proven cervical cancer. 2. FIGO stage IVb or recurrent cervical cancer. Previous one or two regimens of chemotherapy is permitted. 3. Patient with assessable tumor. 4. ECOG PS: 0 to 2.
Key exclusion criteria	1. Previous paclitaxel or carboplatin administration within 6 months of registration. 2. Any active concomitant malignancy. 3. Severe comorbidity.
Target sample size	30

Research contact person
Name of lead principal investigator	Shoji Nagao
Organization	Hyogo Cancer Center
Division name	Gynecologic Oncology
Address	13-70Kitaoji-cho, Akashi-city
TEL	078-929-1151
Email	nagao@hp.pref.hyogo.jp

Public contact
Name of contact person	Shoji Nagao
Organization	Hyogo Cancer Center
Division name	Gynecologic Oncology
Address	13-70Kitaoji-cho, Akashi-city
TEL	078-929-1151
Homepage URL
Email	nagao@hp.pref.hyogo.jp

Sponsor
Institute	Hyogo Cancer Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2016 Year 09 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 14 Day
Anticipated trial start date	2016 Year 07 Month 15 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	2016 Year 09 Month 23 Day
Last modified on	2016 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027794