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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000239
Receipt No. R000000296
Scientific Title A phase I/II study of concurrent chemoradiation with irinotecan hydrochloride(CPT-11) and cisplatin(CDDP) for uterine cervical cancer. (KCOG 0328)
Date of disclosure of the study information 2005/09/16
Last modified on 2007/09/24

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Basic information
Public title A phase I/II study of concurrent chemoradiation with irinotecan hydrochloride(CPT-11) and cisplatin(CDDP) for uterine cervical cancer. (KCOG 0328)
Acronym A phase I/II study of concurrent chemoradiation with CPT-11 and CDDP for uterine cervical cancer. (KCOG 0328)
Scientific Title A phase I/II study of concurrent chemoradiation with irinotecan hydrochloride(CPT-11) and cisplatin(CDDP) for uterine cervical cancer. (KCOG 0328)
Scientific Title:Acronym A phase I/II study of concurrent chemoradiation with CPT-11 and CDDP for uterine cervical cancer. (KCOG 0328)
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 determine the recommended dose of irinotecan hydrochloride (CPT-11) combined with 30mg/m2 of cisplatin (CDDP) and concurrent radiotherapy in patients with cervical cancer, and to evaluate tumor response and feasibility with this therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events
Feasibility
Response rate
Key secondary outcomes 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 Patients receive radiotherapy and intravenous administration of CPT-11 and CDDP once a week, simultaneously. Traetment repeats weekly for 5 courses in the absence of unacceptable toxicity.
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
16 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria 1) Histologically confirmed primary uterine cervical cancer.
2) Clinical stage III to IVa and IVb by para-aortic lymphnode metastasis.
3) Disease with measurable lesion according to RECIST.
4) ECOG Performance Status 0-1.
5) No prior chemothrapy and radiotherapy.
6) Adequate bone marrow, cardiac, liver, lung, kidney functions.
a) WBC> 3,000/mm3, < 12,000/mm3
b) Hemoglobin > 10.0g/dl,
c) Platelets > 100,000/mm3,
d) T-Bil< 1.5 mg/dl,
e) AST(GOT)< 2 times of normal upper limits,
f) ALT(GPT)< 2 times of normal upper limits,
g) Cr< normal upper limits,
h) BUN< normal upper limits,
i) CCr> normal lower limits,
j) PaO2> 60torr,
k) ECG normal.
7) Expected survival more than 3months. 8) Fully written informed consent.
Key exclusion criteria 1) Severe complications:
a) infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis,
b) massive pleural effusion or ascites,
c) uncontrollable diabetes mellitus,
d) other complications which suffer from progressing study.
2) Co-existence of active other malignancies.
3) The patients with prior radiotherapy whose treatment area of irradiation will be overlaid to ex-treatment area.
4) Pregnant or expected to be pregnant and breast feeding mother.
5) Known severe hypersensitivity to agent.
6) Whom the investigator think unappropriate as a candidate.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimihiko Ito
Organization Kansai Rosai Hospital
Division name Obstetrics and Gynecology
Zip code
Address 3-1-69 Inabaso, Amagasaki, Hyogo, Japan
TEL 06-6416-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kimihiko Ito
Organization Kansai Rosai Hospital
Division name Obstetrics and Gynecology
Zip code
Address 3-1-69 Inabaso, Amagasaki, Hyogo, Japan
TEL 06-6416-1221
Homepage URL http://kcog
Email kimihiko-ito@kanrou.net

Sponsor
Institute Kansai Clinical Oncology Group (KCOG)
Institute
Department

Funding Source
Organization Kansai Clinical Oncology Group (KCOG)
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
Email

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
2005 Year 09 Month 16 Day

Related information
URL releasing protocol http://kcog
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
2003 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2003 Year 03 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 01 Month 01 Day
Date trial data considered complete
2007 Year 01 Month 01 Day
Date analysis concluded
2007 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 16 Day
Last modified on
2007 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000296

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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