UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000239 |
|---|---|
| Receipt number | 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 20:43:38 |
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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
| Obstetrics 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
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
kimihiko-ito@kanrou.net
Sponsor or person
Institute
Kansai Clinical Oncology Group (KCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000296
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