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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001042
Receipt No. R000001190
Scientific Title Multi-institutional phase II study of concurrent chemoradiotherapy using high-dose-rate intracavitary brachytherapy for locally advanced uterine cervical cancer.
Date of disclosure of the study information 2008/02/19
Last modified on 2018/08/13

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Basic information
Public title Multi-institutional phase II study of concurrent chemoradiotherapy using high-dose-rate intracavitary brachytherapy for locally advanced uterine cervical cancer.
Acronym CCRT for locally advanced cervical cancer
Scientific Title Multi-institutional phase II study of concurrent chemoradiotherapy using high-dose-rate intracavitary brachytherapy for locally advanced uterine cervical cancer.
Scientific Title:Acronym CCRT for locally advanced cervical cancer
Region
Japan

Condition
Condition Locally advanced cervical cancer
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of concurrent chemoradiotherapy with radiotherapy of Japanese standard schedule for patients with locally advanced (FIGO stage III and IVA) uterine cervical cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Feasibility, Toxicity, Tumor response, Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Concurrent chemoradiotherapy: CCRT
Cisplatin (40mg/m2, weekly, 5 courses)
Radiothrapy: BED 74-78Gy10
External beam: whole pelvis 50-50.4Gy/25-28fr (CS after 30-41.4Gy)
HDR-ICBT : 6Gy x 3-4 (point A)
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)Pathologically confirmed cervix cancer
2)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
3)20 years-old<=age<=75 years-old
4)FIGO Stage3a,3b,4a
5)No prior treatments
6)Adequate bone marrow,cardiac,pulmonry function
Absolute neutrophil count:
>= 2,000/mm3
Hemoglobin: >= 10.0g/dL
Platelet count: >= 100,000/mm3
Bilirubin: <1.5mg/dL
AST/ALT: <100 IU/l
Serum creatinine: < 1.2mg/dL
creatinine clearance > 50 ml/min
ECG Normal
7)Written informed consent
Key exclusion criteria 1) Patients with stump cancer
2) Patients with active infections
3) Patients with hydronephrosis
4) Patients with unstable angina, history of cardiac infarction within 6 months, or arrhythmia that requires medical treatment
5) Patients with serious complications
6) Patients who previously received pelvic radiotherapy
7) Patients with active concomitant malignancy
8) Patients who have undergone surgical staging
9) Patients with psychiatric illness that would prevent informed consent
10) Patients during pregnancy or breast-feeding, or unwilling to the use of contraception
11)Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Toita
Organization University of the Ryukyus
Division name Department of Radiology, Graduate School of Medical Science
Zip code
Address 207 Uehara, Nishinhara-cho, Okinawa, 903-0215, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Toita
Organization JGOG1066 Coordinating Office
Division name University of the Ryukyus
Zip code
Address 207 Uehara, Nishinhara-cho, Okinawa, 903-0215, Japan
TEL 03-3353-1211
Homepage URL http://www.jgog.gr.jp/
Email gog1066@jgog.gr.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Japanese Gynecologic Oncology Group
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
2008 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/21331768
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
2007 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 02 Month 19 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001190

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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