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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002937
Receipt No. 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

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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
Obsterics 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
Institute Japanese Cancer Clinical Research Organization(JACCRO)
Institute
Department

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
URL(English) https://upload.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


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