UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026063
Receipt number R000029934
Scientific Title A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer.
Date of disclosure of the study information 2017/02/10
Last modified on 2019/02/11 14:10:56

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Basic information

Public title

A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer.

Acronym

JGOG1079

Scientific Title

A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer.

Scientific Title:Acronym

JGOG1079

Region

Japan


Condition

Condition

Stage IVB, recurrent or persistant cervical cancer

Classification by specialty

Endocrinology and Metabolism Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical benefit of Bevacizumab treatment in combination with chemotherapy of Paclitaxel plus Carboplatin for patients with Stage IVB, recurrent or persistant cervical cancer as measured by the investigator assessed progression free survival(PFS).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression Free Survival: PFS

Key secondary outcomes

Overall Response Rate: ORR
Overall Survival: OS
Time to Treatment Failure: TTF
Safety


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 day1
Carboplatin AUC=5 day1
Bevacizumab 15mg/kg day1
tri-weekly

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.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
2.More than 20 years old
3.ECOG Performance Status: 0-2
4.Life expectancy of >= 90 days
5.Histologically confirmed cervical cancer by histopathologic examination of uterine cervix
6.Patients with a diagnosis of confirmed cervical cancer such as squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
7.Patients can be included if they have measurable diseases.
8.Adequate following organ function.

Key exclusion criteria

1.Patient who has received any cheotherapy except for CCRT
2.Patient with perforation of the digestive tract and severe fistula within 6 months before registration
3.Patient with a history of hypersensitivity to the drug used in combination to bevacizumab
4.Patient with active infection at registration
5. Patient with uncontrolled hypertension at registration
6.Patient suspected or diagnosed as arterial thromboembolism (cerebral infarction, myocardial infarction, etc.) at registration
7.Patient who is judged inappropriate to participate in this study by the attending physician

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuhiro Takeshima, M.D.

Organization

Cancer Institute Hospital

Division name

Department of Gynecology

Zip code


Address

3-8-31, Ariake, Koutou-ku,Tokyo, 135-8550 Japan

TEL

03-3520-0111

Email

nobuhiro.takeshima@jfcr.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Maki Matoda, M.D.

Organization

Cancer Institute Hospital

Division name

Department of Gynecology

Zip code


Address

3-8-31, Ariake, Koutou-ku,Tokyo, 135-8550 Japan

TEL

03-3520-0111

Homepage URL


Email

maki.matsumura@jfcr.or.jp


Sponsor or person

Institute

Japan Gynecologic Oncology Group:JGOG

Institute

Department

Personal name



Funding Source

Organization

Japan Gynecologic Oncology Group:JGOG

Organization

Division

Category of Funding Organization

Other

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 02 Month 10 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

No longer recruiting

Date of protocol fixation

2017 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 15 Day

Last follow-up date

2020 Year 09 Month 01 Day

Date of closure to data entry

2020 Year 09 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 09 Day

Last modified on

2019 Year 02 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029934


Research Plan
Registered date File name
2018/02/10 JGOG1079_Protcol_Ver.1.1.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name