UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of bevacizumab combined with chemotherapy (paclitaxel/carboplatin) as postoperative adjuvant therapy for cervical cancer
Title of the study (Brief title)	Phase II Study of bevacizumab combined with chemotherapy (paclitaxel/carboplatin) as postoperative adjuvant therapy for cervical cancer
Region	Japan

Condition
Condition	Cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluated efficacy and safety of bevacizumab in combination with paclitaxel and carboplatin as adjuvant chemotherapy for cervical cancer completely resected by surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2 year relapse-free survival rate
Key secondary outcomes	Adverse event occurrence rate Chemotherapy completion rate 5 year overall survival rate 5 year relapse-free survival rate

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=5) bevacizumab(15mg/kg) Total 6 cycles administered every 3weeks.
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	70 years-old >=
Gender	Female
Key inclusion criteria	1. Patient who are informed consent about participation in this study and received written consent. 2.ECOG Performance Status: 0-1 3.Cervical cancer stage IB-IIB(FIGO2008) 4.Patients who undergo radical hysterectomy and have one or more of the following conditions under postoperative pathological findings. (1)The depth of cervical stromal infiltrate exceeds 2/3. (2)The depth of cervical stromal infiltration ranges from 1/3 to 2/3 and lymph-vascular invasion positive. (3)Pelvic lymph node metastasis positive. (4)Resection margin positive. 5. Patients without residual lesions after surgery. 6. Patients without prior treatment other than surgery. 7. Patients who are expected to begin chemotherapy within 6 weeks after surgery. 8. Patients whose main organs (bonemarrow,heart,liver,kidney,etc.) function are preserved.
Key exclusion criteria	1. Patients whose pathologically confirmed para aortic lymph node (PAN) metastasis. Patients who are suspected of PAN metastasis by preoperative imaging (CT with a short diameter of 10mm or more, suspicious metastasis with PET/CT, can't be registered if pathological negative is not confirmed. 2. Patients with active double cancer (synchronous double cancer and metachronous double cancer with disease-free period within 5 years). 3. Patient who have been treated with anti-VEGF and anti-VEGFR formulations. 4. Patients with symptomatic cerebrovascular disorders. 5. Patients with a high probability of bleeding due to congenital hemorrhagic diathesis, abnormal coagulation, etc. 6. Patients with severe cardiovascular disorders (such as poor control hypertension). 7. Patients with clinical symptoms of intestinal obstruction. 8. Patients with infection requiring systemic administration such as antibiotics, antivirals, antifungal drugs at registration. 9. Patients who received radiotherapy or chemotherapy before surgery.
Target sample size	63

Research contact person
Name of lead principal investigator	Yoichi Aoki
Organization	University of the Ryukyus
Division name	Graduate School of Medical Science University of the Ryukyus
Address	207 Uehara, Nishihara, Okinawa
TEL	098-895-1177
Email	yoichi@med.u-ryukyu.ac.jp

Public contact
Name of contact person	Wataru Kudaka
Organization	University of the Ryukyus Hospital
Division name	Obstetrics and gynecology
Address	207 Uehara, Nishihara, Okinawa
TEL	098-895-1177
Homepage URL
Email	wkudaka@med.u-ryukyu.ac.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

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)

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	2017 Year 09 Month 28 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 25 Day
Anticipated trial start date	2017 Year 09 Month 28 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	2017 Year 09 Month 27 Day
Last modified on	2018 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031308