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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000155 |
Receipt No. | R000000223 |
Scientific Title | randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA |
Date of disclosure of the study information | 2005/10/01 |
Last modified on | 2017/06/12 |
Basic information | ||
Public title | randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA | |
Acronym | randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA | |
Scientific Title | randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA | |
Scientific Title:Acronym | randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA | |
Region |
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Condition | ||
Condition | ovarian cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The combination of paclitaxel and carboplatin every 3 weeks is considered as a standard first line chemotherapy for the of patients with advanced ovarian cancer. However,this treatment often produced severe neurotoxicity. A randomized trial demonstrated that the combination of docetaxel and carboplatin had a similiar efficacy to paclitaxel and carboplatin. The treatment had less neurotoxicity,but greater myelosuppression compared with paclitaxel-carboplatin. On the other hand, and weekly paclitaxel as substitute for 3 weeks and carboplatin was reported to have similiar response and less neurotoxicity. Our aim is to examine efficacy ety of docetaxel-carboplatin versus weekly paclitaxel and carboplatin for advanced ovarian cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | progression free survival |
Key secondary outcomes | quality of life ,safety |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Single blind -participants are blinded |
Control | Uncontrolled |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | docetaxel and carboplatin | |
Interventions/Control_2 | weekly paclitaxel and carboplatin | |
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 | Patients with histologically or cytologically confirmed epitheral ovarian cancer, fallopian tubal cancer or peritoneal cancer. performance status(ECOG)0-2. no prior chemotherapy. adequate levels of bone marrow,hepatic,and renal function. n. no heart failure and pulmonary disease. no active infection. no
other malignancies. signing of an informed consent document. |
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Key exclusion criteria | pregnant or nursing woman
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | osaka medical college | ||||||
Division name | department of obstetrics and gynecology | ||||||
Zip code | |||||||
Address | Daigakucho2-7 Takatuki city Osaka Japan | ||||||
TEL | 0726-83-1221 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Kyoto Prefectual University | ||||||
Division name | department of obstetrics and gynecology | ||||||
Zip code | |||||||
Address | Kajiicho465 Kamigyoku Kyoto city Japan | ||||||
TEL | 075-251-5560 | ||||||
Homepage URL | |||||||
hosokawa@koto.kpu-m.ac.jp |
Sponsor | |
Institute | Osaka Medical College |
Institute | |
Department |
Funding Source | |
Organization | Kansai Clinical Oncology Group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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 | |
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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=R000000223 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |