UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002937
Receipt number R000003572
Scientific Title Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel chemotherapy for locally advanced cervical carcinoma (JACCRO GY-01)
Date of disclosure of the study information 2009/12/24
Last modified on 2016/02/17 07:56:04

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Basic information

Public title

Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel chemotherapy for locally advanced cervical carcinoma
(JACCRO GY-01)

Acronym

Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel chemotherapy for locally advanced cervical carcinoma
(JACCRO GY-01)

Scientific Title

Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel chemotherapy for locally advanced cervical carcinoma
(JACCRO GY-01)

Scientific Title:Acronym

Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel chemotherapy for locally advanced cervical carcinoma
(JACCRO GY-01)

Region

Japan


Condition

Condition

Uterine cervical carcinoma

Classification by specialty

Obstetrics and Gynecology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the effectiveness and safety of CCRT using standard radiotherapy schedule in Japan and weekly administration of CDDP 30mg/m2 + PTX 50mg/m2 for the locally-advanced cervical cancer (stage IIIa - IVa) that is evaluated for no distant metastasis and unresectable cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Freedom-from-progression at two years

Key secondary outcomes

(1) Therapy completion rate
(2) Onset rate of adverse event by grade
(3) Complete response rate
(4) Two-year survival rate
(5) Two-year progression-free rate in the pelvis
(6) Two-year incidence of distant metastasis


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 Maneuver

Interventions/Control_1

Patients receive radiotherapy and intravenous administration of cispaltin and paclitaxel once a week, simultaneously. Traetment repeats weekly for 5 to 7 courses in the absence of unacceptable toxicity.

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 whose primary lesion is histologically diagnosed as cervical cancer.
2) Patient whose performance status (PS) is 0 or 1.
3) Patient whose age is over 20 and below 70 at the time of registration.
4) Patient whose clinical stage is IIIa, IIIb and IVa and who has no enlargement of para-aortic lymph node over 10mm with CT within four weeks before registration.
5) Patient who has no pretreatment history of radiotherapy, chemical therapy and operation for cervical cancer.
6) Patient who preserves function of main organs.
7) Patient whose written consent for participation in this test has been obtained in person.

Key exclusion criteria

1) Patient with stump cancer
2) Patient who has an active infection.
3) Patient who has a hydronephrosis.
4) Patient who has myocardial infarction, unstable angina and uncontrolled irregular heartbeat within six months before registration.
5) Patient who has a serious complication.
6) Patient who has a radiotherapy history in the pelvic region.
7) Patient who has an active double cancer. However, cancers in situ that are considered as recovered by local treatment or legions equivalent to intramucosal cancer are not included in the active double cancers.
8) Patient who underwent exploratory laparotomy for cervical cancer.
9) Patient who is complicated by mental disease or psychological symptom and considered difficult to participate in the test.
10) Patient who is pregnant or of child-bearing potential or breast-feeding.
11) Patient who is diagnosed as a pyometra and there is no improvement in pyometra and infection despite the implementation of appropriate measures.
12) Other cases where doctors in attendance consider patients inappropriate.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Takizawa

Organization

Cancer Institute Hospital

Division name

Gynecology

Zip code


Address

Ariake 3-10-6, Koutou-ku, Tokyo 135-8550, Japan.

TEL

03-3520-0111

Email

ken.takizawa@jfcr.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Umayahara

Organization

Cancer Institute Hospital

Division name

Gynecology

Zip code


Address

Ariake 3-10-6, Koutou-ku, Tokyo 135-8550, Japan.

TEL

03-3520-0111

Homepage URL


Email

kenji.umayahara@jfcr.or.jp


Sponsor or person

Institute

Japanese Cancer Clinical Research Organization(JACCRO)

Institute

Department

Personal name



Funding Source

Organization

Japanese Cancer Clinical Research Organization(JACCRO)

Organization

Division

Category of Funding Organization

Non profit foundation

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

2009 Year 12 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2009 Year 11 Month 21 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2013 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 12 Month 24 Day

Last modified on

2016 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name