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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016169
Receipt No. R000018769
Official scientific title of the study 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

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Basic information
Official scientific title of the study 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
Title of the study (Brief title) Cervix IV
Region
Japan

Condition
Condition uterine cervical cancer
Classification by specialty
Obsterics 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 Michiya Suzuki
Organization National Institute of Radiological Sciences
Division name Research Center Hospital for Charged Particle Therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL 043-206-3306
Email waka@nirs.go.jp

Public contact
Name of contact person Masaru Wakatsuki
Organization National Institute of Radiological Sciences
Division name Research Center Hospital for Charged Particle Therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba-city, Chiba, 263-8555 JAPAN
TEL 043-206-3306
Homepage URL
Email wakkun100@yahoo.co.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 02 Month 15 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018769

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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