UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001042 |
|---|---|
| Receipt number | 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 13:49:59 |
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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
| Obstetrics 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
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/
gog1066@jgog.gr.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001190
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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