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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000017808 |
Receipt No. | R000020631 |
Scientific Title | Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer |
Date of disclosure of the study information | 2015/06/05 |
Last modified on | 2015/06/04 |
Basic information | ||
Public title | Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer | |
Acronym | Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer | |
Scientific Title | Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer | |
Scientific Title:Acronym | Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer | |
Region |
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Condition | ||
Condition | Cervical cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | disease free survival |
Key secondary outcomes |
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 | radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin | ||
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.Cervical cancer patients stage IB2, IIA2, IIB, and III
2. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 3. Main medical conditions must be well-controlled 4. Have a life expectancy of at least 3 months, as estimated by the investigator 5. Subject must provide written informed consent and be wiling and able to comply with all aspects of the protocol 6. Laboratory results within the 1 week prior to Registration must be as follows: -Absolute neutrophil count > 1,500 cells/mm3 -Bilirubin < 1.5 mg/dL -Creatinine < 1.5 mg/dL -Asparatate Aminotransferse (AST) and Alanine Aminotransferase (ALT) < 100 U/L -Platelet count > 100,000 cells/mm3 7. Must evaluate MRI and CT scan within 1 month prior to registration |
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Key exclusion criteria | 1. Having fever more than 38.0 degrees
2. Active serious systemic disease, including active bacterial or fungal infection. 3. Clinically siginificant heart disease or other complications. 4. Evidence of other active invasive malignancy. 5. Previous treatment with Taxens and/or Platinums. 6. Any medical or other condition that, in the opinion of the investigator, would preclude the subjects' participation in a clinical study including medical contraindications. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saitama Medical university International Medical Center | ||||||
Division name | Gynecogic Oncology | ||||||
Zip code | |||||||
Address | 1397-1 Yamane, Hidaka-city, Saitama, Japan | ||||||
TEL | +81-42-984-4111 | ||||||
akirak@saitama-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Saitama Medical university International Medical Center | ||||||
Division name | Gynecogic Oncology | ||||||
Zip code | |||||||
Address | 1397-1 Yamane, Hidaka-city, Saitama, Japan | ||||||
TEL | +81-42-984-4111 | ||||||
Homepage URL | |||||||
akirak@saitama-med.ac.jp |
Sponsor | |
Institute | Saitama Medical university International Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Saitama Medical university International Medical Center |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | Unpublished |
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 | Open public recruiting | ||||||
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 analysis concluded |
Other | |
Other related information |
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=R000020631 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |