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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000148 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | uterine cancer (squamous cell carcinoma, adeno- and/or adenosquamous cell carcinoma, endometrial carcinoma, carcinosarcoma) | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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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. | ||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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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 |