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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000239 |
Receipt No. | R000000296 |
Scientific Title | A phase I/II study of concurrent chemoradiation with irinotecan hydrochloride(CPT-11) and cisplatin(CDDP) for uterine cervical cancer. (KCOG 0328) |
Date of disclosure of the study information | 2005/09/16 |
Last modified on | 2007/09/24 |
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 |
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Condition | |||
Condition | Uterine cervical cancer | ||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
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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 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. |
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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. |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kansai Rosai Hospital | ||||||
Division name | Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 3-1-69 Inabaso, Amagasaki, Hyogo, Japan | ||||||
TEL | 06-6416-1221 | ||||||
Public contact | |||||||
Name of contact person |
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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 | ||||||
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 |
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IRB Contact (For public release) | |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://kcog |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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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=R000000296 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |