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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029306
Receipt No. R000031308
Scientific Title Phase II Study of bevacizumab combined with chemotherapy (paclitaxel/carboplatin) as postoperative adjuvant therapy for cervical cancer
Date of disclosure of the study information 2017/09/28
Last modified on 2018/11/06

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Basic information
Public title Phase II Study of bevacizumab combined with chemotherapy (paclitaxel/carboplatin) as postoperative adjuvant therapy for cervical cancer
Acronym Phase II Study of bevacizumab combined with chemotherapy (paclitaxel/carboplatin) as postoperative adjuvant therapy for cervical cancer
Scientific Title Phase II Study of bevacizumab combined with chemotherapy (paclitaxel/carboplatin) as postoperative adjuvant therapy for cervical cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoichi Aoki
Organization University of the Ryukyus
Division name Graduate School of Medical Science University of the Ryukyus
Zip code
Address 207 Uehara, Nishihara, Okinawa
TEL 098-895-1177
Email yoichi@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wataru Kudaka
Organization University of the Ryukyus Hospital
Division name Obstetrics and gynecology
Zip code
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)

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
2017 Year 09 Month 28 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 25 Day
Date of IRB
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

Other
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

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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