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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003585
Receipt No. R000004344
Official scientific title of the study A phase I/II clinical trial of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix
Date of disclosure of the study information 2010/05/10
Last modified on 2010/05/09

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Basic information
Official scientific title of the study A phase I/II clinical trial of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix
Title of the study (Brief title) Carbon-ion radiotherapy and concurrent chemotherapy for locally advanced adenocarcinoma of the uterine cervix
Region
Japan

Condition
Condition locally advanced adenocarcinoma of the uterine cervix
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of carbon-ion radiotherapy and concurrent cisplatin chemotherapy for locally advanced adenocarcinoma of the uterine cervix
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I study
Acute toxicity (to determine the maximum tolerated dose and the recommended dose for phase II study)
Phase II study
Response rate
Key secondary outcomes Phase I study
Response rate at the RD level
Phase II study
Acute and late toxicity
Local control
Progression-free survival
Overall survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A total dose of 68.0-74.4 GyE in 20 fractions of carbon-ion radiotherapy is administered for 5 weeks.
Cisplatin 40mg/m2 is administered weekly for 5 weeks concurrently with 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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key inclusion criteria 1. Pathologically proven adenocarcinoma or adenosquamous carcinoma of the uterine cervix
2. Stage IIB, III, or IVA disease (FIGO 1994)
3. No enlarged para-aortic lymph node by CT scan
4. Measurable disease
5. Age; 20-70 years
6. PS; WHO 0-2
7. Patients with unresectable disease or patients who refuse surgery
8. No prior surgery or chemotherapy to cervical cancer
9. Adequate bone marrow, hepatic, and renal functions;
white blood cells >= 3000/m3
hemoglobin >= 10g/dl
platelets >= 100,000/m3
total bilirubin <= 1.5mg/dl
AST/ALT <= 100IU/dl
serum creatinine <= 1.5mg/dl
creatinine clearance >= 50ml/min
ECG: within normal range
10. Life expectancy; longer than 6 months
11. Written informed consent
Key exclusion criteria 1. Severe concomitant illness (e.g. uncontrolled heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infectious disease, active gastric ulcer, uncontrolled mental illness)
2. History of other malignancies within the past 5 years
3. Tumor invading directly to the rectum
4. Prior radiotherapy to the pelvis
5. Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size 32

Research contact person
Name of lead principal investigator Shingo Kato
Organization National institute of radiological sciences of Japan
Division name Research center for charged particle therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan
TEL
Email

Public contact
Name of contact person
Organization National institute of radiological sciences of Japan
Division name Research center for charged particle therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba, 263-8555, Japan
TEL 043-206-3360
Homepage URL
Email

Sponsor
Institute Research center for charged particle therapy, National institute of radiological sciences of Japan
Institute
Department

Funding Source
Organization MEXT Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 05 Month 10 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 03 Month 25 Day
Anticipated trial start date
2010 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
2010 Year 05 Month 09 Day
Last modified on
2010 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004344

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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