UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer
Acronym	CCRT with CPT-11
Scientific Title	A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer
Scientific Title:Acronym	CCRT with CPT-11
Region	Japan

Condition
Condition	uterine cancer (squamous cell carcinoma, adeno- and/or adenosquamous cell carcinoma, endometrial carcinoma, carcinosarcoma)
Classification by specialty	Obsterics and gynecology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Assessment of feasibility and usefullness and definition of recommended dose of CPT-11 in concurrent cehmoradiotherapy for advanced or recurrent uterine cancer
Basic objectives2	Others
Basic objectives -Others	progression free survival
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	adverse events feasibility response
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 Maneuver
Interventions/Control_1	In chemoradiotherapy with Irinotecan (CPT-11), the determination of its maximum torelated dose and/or recommended dose and the estimation of its effecacy for advanced/recurrent uterine cancer.
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	75 years-old >
Gender	Female
Key inclusion criteria	(1) Histologically and/or clinically confirmed uterinecancer newly diagnosed and recurrent cases.(2)disease with measurable lesion.(3) pelvic/para aortic lyphnodes metastases (4)No lung metastases,(5)previous treatments were as follows: chemotherapy(including immune therapy using biological response modifier) and radiotherapy mustnot be done within 4 weeks before recruitment(6)ECOG Performance Status 0-1, (7)Expected survival time is more than 3months (8) Adequate bone marrow function,no severe complications on heart, lung, liver, kidney functions:a)WBC>3,000/mm3, b) platelets >100,000/mm3, c) Hemoglobin >9.5 g/dl, d) AST, ALT < 2 times of normal limits ( exclude of liver metastases), e) T-Bil< 1.5 mg/dl, f) S-Crn < 1.5 mg/dl, g) PaOz> 60 Torr, h) ECG normal, 9) fully written informed consent will be obtained
Key exclusion criteria	Exclusion criteria (1)the patients with prior radiotherapy whose treatment area of irradiation will be overlaid to ex-treatment area (2)co-existence of active other malignancies (3)severe complications, such as a)infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis b)too much pleural effusion, ascitic or abdominal ascites c)uncontrollable diabetis mellitus d)other complications which suffer from progressing study (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 Satoshi Takeuchi
Organization	National Hospital Organization Kobe Medical Center
Division name	Gynecologic Oncology
Zip code
Address	3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan
TEL	078-791-0111
Email

Public contact
Name of contact person	1st name Middle name Last name Satoshi Takeuchi
Organization	Natinonal Hospital Organization Kobe Medical Center
Division name	Gynecologic Oncology
Zip code
Address	3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan
TEL	078-791-0111
Homepage URL	http://kcog.
Email	s-take-kmc@zeus.eonet.ne.jp

Sponsor
Institute	National Hospital Organization Kobe Medical Center
Institute
Department

Funding Source
Organization	Kansai Clinical Oncology Group (KCOG)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kansai Rosai Hospital, Nara prefectural Nara Hospital, Kyoto Medical College, Mie University,Nara prefectural Nara Medical college
Name of secondary funder(s)	Japanese Foundation for Multidisciplinary Treatment of Cancer

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 09 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	The status of the recruiting patients and chief adverse events were reported at the meeting of the Japanese Foundation for Multidisciplinary Treatemtn of Cancer and the International Gyneclogical Cancer Society held on last Novenmber. Now the recruiting was finished. At DL4, two patients out of three revealed dose limitting adverse events. MTD was decided as a dose level 4, ie, 60mg/sqm.
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	2001 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date	2002 Year 08 Month 01 Day
Last follow-up date	2008 Year 09 Month 01 Day
Date of closure to data entry	2008 Year 10 Month 01 Day
Date trial data considered complete	2008 Year 10 Month 01 Day
Date analysis concluded	2009 Year 01 Month 01 Day

Other
Other related information	None

Management information
Registered date	2005 Year 09 Month 09 Day
Last modified on	2008 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000214

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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