UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016169 |
|---|---|
| Receipt number | R000018769 |
| Scientific Title | A phase I/II clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes in locally advanced squamous cell carcinoma of the uterine cervix using carbon-ion beams |
| Date of disclosure of the study information | 2015/01/09 |
| Last modified on | 2015/01/09 13:44:45 |
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Basic information
Public title
A phase I/II clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes in locally advanced squamous cell carcinoma of the uterine cervix using carbon-ion beams
Acronym
Cervix IV
Scientific Title
A phase I/II clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes in locally advanced squamous cell carcinoma of the uterine cervix using carbon-ion beams
Scientific Title:Acronym
Cervix IV
Region
| Japan |
Condition
Condition
uterine cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of prophylactic extended-field C-ion RT for locally advanced squamous cell carcinoma of the uterine cervix.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Acute toxicity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Prophylactic extended-field (Pelvic and para-aorta lymph node regions) Carbon-ion radiotherapy
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
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Pathologically proven squamous cell carcinoma of the uterine cervix
2. International Federation of Gynecology and Obstetrics (FIGO 1994) Stage IIB with tumor size > 4 cm in diameter, III, or IVA disease without rectal invasion
3. Patient does not have para-aortic lymph nodes > 1 cm in minimum diameter on CT image
4. Tumor must be grossly measurable
5. Age < 80 years
6. World Health Organization performance status < 3
7. Adequate bone marrow function; WBC > 3000 cells/mm3, Platelets > 100,000 cells/mm3, Hemoglobin > 10.0 g/dl
8. Estimated life expectancy > 6 months
9. Patient provides written informed consent to participate in this study before initiation of therapy.
Key exclusion criteria
1. Severe co-morbidity; severe pelvic infection, severe psychological illness etc.
2. Active synchronous cancer
3. Prior radiotherapy to the pelvic or para-aortic region
4. Prior chemotherapy
5. Medical, psychological or other factor deciding ineligibility by attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiya Suzuki |
Organization
National Institute of Radiological Sciences
Division name
Research Center Hospital for Charged Particle Therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL
043-206-3306
waka@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Wakatsuki |
Organization
National Institute of Radiological Sciences
Division name
Research Center Hospital for Charged Particle Therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL
043-206-3306
Homepage URL
wakkun100@yahoo.co.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
放射線医学総合研究所（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2006 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 09 | Day |
Last modified on
| 2015 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018769
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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