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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000027775 |
Receipt No. | R000031829 |
Scientific Title | Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2020/12/17 |
Basic information | ||
Public title | Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer | |
Acronym | GEAR study | |
Scientific Title | Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer | |
Scientific Title:Acronym | GEAR study | |
Region |
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Condition | |||
Condition | pancreatic cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To analyze the efficacy of Gemcitabine/nab-Paclitaxel regimen for locally advanced pancreatic cancer with arterial invasion |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | R0 resection rate |
Key secondary outcomes | QOL assessment, Effectiveness of preoperative chemotherapy, pathological response rate, incidence rate of adverse events, relative dose intensity |
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 | Gemcitabine + nab-Paclitaxel regimen (Gemcitabine 1000mg/m2 nab-Panclitaxicel 125mg/2: day1,8,15 28day/course:2-4 course) and operation | ||
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) Histologically confirmed adenocarcinoma or adenosquamous carcinoma
2) BR-A pancreatic cancer 3) With measurable lesion(s) 4) Without distant metastasis 5) Without any further treatment for pancreatic cancer 6) Age more than 20 or less than 75 7)ECOG Performance Status 0-1 8) Without history of chemotherapy or radiotherapy 9)Adequate organ function 10) Sensory/motor neuropathy: None or Grade 1 11) Written informed consent |
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Key exclusion criteria | 1) Present or previous (within 5 years) double cancer except for carcinoma in situ
2) Pregnant females, possibly pregnant females, females feeding babies and males wishing partners' pregnancy 3) Active infection 4) Severe mental disorder 5) Interstitial pneumonia or pulmonary fibrosis 6) Severe heart disease, liver disease and uncontrolled diabetes 7) Patients positive for HBs antigen 8) Patients inadequate for enhanced CT scan 9) Severe allergy for drugs 10) Patients with inadequate condition |
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Target sample size | 37 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University | ||||||
Division name | Department of Surgery and Oncology | ||||||
Zip code | 812-8582 | ||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 092-622-5441 | ||||||
mnaka@surg1.med.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyushu University | ||||||
Division name | Department of Surgery and Oncology | ||||||
Zip code | 812-8582 | ||||||
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 092-622-5441 | ||||||
Homepage URL | |||||||
yoshi-m@surg1.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Kyushu-Yamaguchi study group of therapy for pancreatobiliary cancer |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
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 Surgery and Oncology, Kyushu University |
Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka |
Tel | 0926425441 |
yoshi-m@surg1.med.kyushu-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 | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 37 |
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 | No longer recruiting | ||||||
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/ctr_e/ctr_view.cgi?recptno=R000031829 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |