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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
