UMIN-CTR Clinical Trial
| Recruitment status | Terminated |
| Unique ID issued by UMIN | UMIN000015917 |
| Receipt No. | R000018524 |
| Scientific Title | Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2019/06/16 (Ver. 5) |
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| Basic information | ||
| Public title | Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma | |
| Acronym | Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma | |
| Scientific Title | Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma | |
| Scientific Title:Acronym | Second line chemotherapy using gemcitabine and docetaxel for soft tissue sarcoma | |
| Region |
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| Condition | ||
| Condition | soft tissue sarcoma except for small round cell tumor | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To evaluate efficacy and safety of second-line chemotherapy using gemcitabine and docetaxel after failure of Adriamycin based chemotherapy. |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Confirmatory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Phase II |
| Assessment | |
| Primary outcomes | reduction of tumor volume
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| Key secondary outcomes | adverse effect |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Single arm |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Historical |
| 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 | GEM (900 mg/m2 day 1, 8) + DOC (70 mg/m2 day 8)
5 courses |
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| 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 | Male and Female | |||
| Key inclusion criteria | patient with soft tissue sarcoma except for small round cell tumor after failure of adriamycin based chemotherapy who expresses his/her assent | |||
| Key exclusion criteria | patient who doesn't show his/her assent
patient considered to be not suitable for participating this trial |
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| Target sample size | 20 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Gifu University school of medicine | ||||||
| Division name | The department of Orthopaedic surgery | ||||||
| Zip code | 502-1194 | ||||||
| Address | 1-1 Yanagido, Gifu | ||||||
| TEL | 0582306333 | ||||||
| a-nagano@lucky.odn.ne.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Gifu University school of medicine | ||||||
| Division name | The department of Orthopaedic surgery | ||||||
| Zip code | 502-1194 | ||||||
| Address | 1-1 Yanagido, Gifu | ||||||
| TEL | 0582306333 | ||||||
| Homepage URL | |||||||
| a-nagano@lucky.odn.ne.jp | |||||||
| Sponsor | |
| Institute | Gifu University school of medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | None |
| 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 | The department of Orthopaedic surgery |
| Address | 1-1 Yanagido, Gifu |
| Tel | 0582306333 |
| a-nagano@lucky.odn.ne.jp | |
| 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 | 岐阜大学病院（岐阜県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | Nothing |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | Nothing | ||||||
| Number of participants that the trial has enrolled | 0 | ||||||
| Results | No participant. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | No participant. |
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| Participant flow | No participant. |
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| Adverse events | No participant. |
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| Outcome measures | No participant. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Terminated | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| 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/icdr_e/ctr_view.cgi?recptno=R000018524 |
