UMIN-CTR Clinical Trial

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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