UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000148
Receipt number R000000214
Scientific Title A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer
Date of disclosure of the study information 2005/09/09
Last modified on 2008/12/22 16:19:20

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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

Obstetrics 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 or person

Institute

National Hospital Organization Kobe Medical Center

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

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

Value
https://center6.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