UMIN-CTR Clinical Trial

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

Cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

University of the Ryukyus

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

09

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

09

Month

27

Day

Last modified on

2018

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031308