UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000008148 |
| Receipt No. | R000009374 |
| Scientific Title | Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU |
| Date of disclosure of the study information | 2012/06/14 |
| Last modified on | 2020/02/13 (Ver. 9) |
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| Basic information | ||
| Public title | Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU | |
| Acronym | Palliative chemotherapy with paclitaxel for pancreato-biliary cancers | |
| Scientific Title | Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU | |
| Scientific Title:Acronym | Palliative chemotherapy with paclitaxel for pancreato-biliary cancers | |
| Region |
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| Condition | ||
| Condition | pancreato-biliary cancers | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | Palliative chemotherapy for pancreato-biliary cancers after failure of gemcitabine and oral S-1 |
| Basic objectives2 | Safety |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | |
| Developmental phase | Phase I |
| Assessment | |
| Primary outcomes | Determination of recommended dose |
| Key secondary outcomes | Assessment of safety, Prolonged survival after failur of S-1 and GEM, Response rate, Disease control rate, Adverse event |
| 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 | Paclitaxel | |
| 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 pancreatobiliary cancer after failure of gemcitabine and 5FU. | |||
| Key exclusion criteria | Patients with a history of anti-cancer agent taxane administration. | |||
| Target sample size | 9 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Kanazawa University Hospital | ||||||
| Division name | Hepato-Biliary-Pancreatic Surgery | ||||||
| Zip code | 920-8641 | ||||||
| Address | 13-1 Takaramachi, Kanazawa | ||||||
| TEL | 076-265-2362 | ||||||
| hidetaji@staff.kanazawa-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Kanazawa University Hospital | ||||||
| Division name | Hepato-Biliary-Pancreatic Surgery | ||||||
| Zip code | 920-8641 | ||||||
| Address | 13-1 Takaramachi, Kanazawa | ||||||
| TEL | 076-265-2362 | ||||||
| Homepage URL | |||||||
| hidetaji@staff.kanazawa-u.ac.jp | |||||||
| Sponsor | |
| Institute | Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery |
| 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 | Department of Gastroenterological Surgery, Kanazawa University |
| Address | 13-1 Takaramachi |
| Tel | 076-265-2000 |
| hidetaji@staff.kanazawa-u.ac.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 | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | DOI: 10.3892/mco.2017.1206 DOI: 10.3892/mco.2018.1579 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | DOI: 10.3892/mco.2017.1206 | ||||||
| Number of participants that the trial has enrolled | 16 | ||||||
| Results | BTC: PR 3, SD 2, PD 1 PDAC: SD 4, PD 6 |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results |
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| Baseline Characteristics | BTC or PDAC patients failure of GEM and 5-FU |
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| Participant flow | See paper |
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| Adverse events | See paper |
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| Outcome measures | See paper |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| 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 |
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| Date trial data considered complete |
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| Date analysis concluded |
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| 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=R000009374 |
