UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008349 |
|---|---|
| Receipt number | R000009819 |
| Scientific Title | A phase I clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes using carbon-ion beams and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2015/07/07 20:51:01 |
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Basic information
Public title
A phase I clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes using carbon-ion beams and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Acronym
Cervix-V (Protocol 1207)
Scientific Title
A phase I clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes using carbon-ion beams and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Scientific Title:Acronym
Cervix-V (Protocol 1207)
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 saftey and the toxicity of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes using carbon ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervix
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Acute toxicity of organ at risks
Key secondary outcomes
Primary response rate by recommended dose in 6 months after treatment
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
| Medicine | Maneuver |
Interventions/Control_1
5 weeks
Carbon ion radiotherapy: 72.0 GyE / 20 fractions
Chemotherapy: weekly cisplatin 30-40 mg / m2 for 5 weeks.
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. Squamous cell carcinoma of the uterine cervix
2. International Federation of Gynecology and Obstetrics (FIGO) Stage IIB(>= 4 cm in diameter), III, or IVA disease
3. No para-aortic lymph nodes >= 1 cm in minimum diameter on CT images
4. The tumor had to be grossly measurable.
5. Age between 20 and 70 years
6. Performance status 0 - 2
7. Patients with no histories of prior chemotherapy or pelvic radiotherapy for cervical cancer
8. Normal organ function
(WBC >= 3000/mm3,Hb >= 10g/dl, Plt>= 100,000/mm3, T-Bil.<= 1.5mg/dl, AST(GOT) and ALT(GPT) <= 100IU/dl, Cre <= 1.5mg/dl, CCR >= 50ml/min, ECG normal or require no treatment
9. Estimated life expectancy of _6 months
10. Written informed consent
Key exclusion criteria
1. Severe complicating illness
2. Active double cancer
3. Rectal invasion
4. History of pelvic radiotherapy
5. History of prior chemotherapy
6. medical, psychological or others reason that primary doctor think ineligible
Target sample size
12
Research contact person
Name of lead principal investigator
| 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
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
http://www.nirs.go.jp/hospital/index.shtml
waka@nirs.go.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
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
放射線医学総合研究所（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.nirs.go.jp/hospital/conform/pdf/06_ic_1207.pdf
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 04 | Day |
Last modified on
| 2015 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009819
