Unique ID issued by UMIN | C000000148 |
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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 |
A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer
CCRT with CPT-11
A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer
CCRT with CPT-11
Japan |
uterine cancer (squamous cell carcinoma, adeno- and/or adenosquamous cell carcinoma, endometrial carcinoma, carcinosarcoma)
Obstetrics and Gynecology | Radiology |
Malignancy
NO
Assessment of feasibility and usefullness and definition of recommended dose of CPT-11 in concurrent cehmoradiotherapy for advanced or recurrent uterine cancer
Others
progression free survival
Exploratory
Explanatory
Phase I,II
adverse events
feasibility
response
progression free survival
overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
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.
20 | years-old | <= |
75 | years-old | > |
Female
(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
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
18
1st name | |
Middle name | |
Last name | Satoshi Takeuchi |
National Hospital Organization Kobe Medical Center
Gynecologic Oncology
3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan
078-791-0111
1st name | |
Middle name | |
Last name | Satoshi Takeuchi |
Natinonal Hospital Organization Kobe Medical Center
Gynecologic Oncology
3-1-1 Nisiociai Suma-Ku Kobe Hyogo-prefecture Japan
078-791-0111
http://kcog.
s-take-kmc@zeus.eonet.ne.jp
National Hospital Organization Kobe Medical Center
Kansai Clinical Oncology Group (KCOG)
Non profit foundation
Japan
Kansai Rosai Hospital, Nara prefectural Nara Hospital, Kyoto Medical College, Mie University,Nara prefectural Nara Medical college
Japanese Foundation for Multidisciplinary Treatment of Cancer
NO
2005 | Year | 09 | Month | 09 | Day |
Partially published
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.
Completed
2001 | Year | 12 | Month | 25 | Day |
2002 | Year | 08 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2009 | Year | 01 | Month | 01 | Day |
None
2005 | Year | 09 | Month | 09 | Day |
2008 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000214
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