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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016852 |
Receipt No. | R000019542 |
Scientific Title | Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer |
Date of disclosure of the study information | 2015/03/23 |
Last modified on | 2020/07/01 |
Basic information | ||
Public title | Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer | |
Acronym | Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer | |
Scientific Title | Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer | |
Scientific Title:Acronym | Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer | |
Region |
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Condition | ||
Condition | locally advanced unresectable pancreatic 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 first line GEM+ nab-PTX combination therapy for locally advanced pancreatic cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | Overall survival, progression free survival, adverse events |
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 | Patients receiving nab-PTX plus gemcitabine will receive 125 mg/m2, nab-PTX as a 30- to
40-minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30- to 40-minute infusion (maximum 40 minutes) for 3 weeks followed by a week of rest. |
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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 | 1) Histlogically proven adenocarcinoma or adeno-squamous carcinoma
2) Unresectable locally advanced pancreatic cancer 3) No prior chemotherapy and radiotherapy for other malignancies 4) Age upper 20 and less than 80 5) ECOG performance status of 0, 1 6) Adequate hematologic, hepatic and renal function 7) Written informed consent |
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Key exclusion criteria | 1) Patients with Distant metastasis
2) Patients with symptomatic pulmonary fibrosis or interstitial pneumonia 3) Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 4) Patients has severe complications, such as heart failure, renal failure ileus and severe mental disorder 5) History of malignancy in the last 3 years 6) History of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease). 7) History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa). 8) Women who are pregnant or expect to be pregnant, or nursing female 9) Others |
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Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kurume university school of medicine | ||||||
Division name | Division of gastroenterology | ||||||
Zip code | 8300011 | ||||||
Address | Kurume-shi | ||||||
TEL | 0942-31-7561 | ||||||
takahashi_kenjirou@med.kurume-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kurume university school of medicine | ||||||
Division name | Division of gastroenterology, multidisciplinary cancer treatment center | ||||||
Zip code | 830-0011 | ||||||
Address | 67 Asahi-machi, Kurume city, Fukuoka | ||||||
TEL | 0942-31-7561 | ||||||
Homepage URL | |||||||
digdug0526@gmail.com |
Sponsor | |
Institute | Kurume university school of medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | The Ethical Committee of Kurume University |
Address | 67 Asahi-machi, Kurume city, Fukuoka |
Tel | 0942-31-7917 |
aro_crc@kurume-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 | 久留米大学病院(福岡県) |
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 | 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 | |
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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=R000019542 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |