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Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GA regimen.
Gemcitabine plus nub-paclitaxel (GA) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GA is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy. On the other hand, incidences of grade 3 or 4 neutropenia, febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy on survival time as a preoperative chemotherapy, the investigators use the NAC-GA regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate Recurrence free survival from the first day of protocol therapy, safety of the protocol therapy(Adverse effect), morbidity based on Clavien Dindo classification of more than Grade 3, response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT (limited only for PET-CT available institutions), chemotherapeutic effect grade based on Evans classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), the overall morbidity rates (Reoperation, rate of re-admission, mortality), number of patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity for borderline resectable pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine plus nab-paclitaxel | Experimental | Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel: Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel | Drug | Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival time from the first day of protocol therapy | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival from the first day of protocol therapy | Up to 60 months | |
| Adverse effect | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | Up to 30 weeks |
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Inclusion Criteria:
Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous
Case with measurable lesion
First line treatment
PS (ECOG) 0-1
>= 20 years old and <80 years old
The following criteria must be satisfied in laboratory tests within 14 days of registration
Written informed consent to participate in this study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ken-ichi Okada, M.D., Ph.D. | Contact | +81-73-441-0613 | okada@wakayama-med.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirosaki University | Not yet recruiting | Hirosaki | Aomori | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37927936 | Derived | Okada KI, Kimura K, Yamashita YI, Shibuya K, Matsumoto I, Satoi S, Yoshida K, Kodera Y, Akahori T, Hirono S, Eguchi H, Asakuma M, Tani M, Hatano E, Ikoma H, Ohira G, Hayashi H, Wan K, Shimokawa T, Kawai M, Yamaue H; NAC-GA investigators. Efficacy and safety of neoadjuvant nab-paclitaxel plus gemcitabine therapy in patients with borderline resectable pancreatic cancer: A multicenter single-arm phase II study (NAC-GA trial). Ann Gastroenterol Surg. 2023 Jul 8;7(6):997-1008. doi: 10.1002/ags3.12712. eCollection 2023 Nov. |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
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| Morbidity based on Clavien Dindo classification of more than Grade3 | Up to 30 weeks |
| Response rate | Up to 12 weeks |
| Chemotherapeutic effect grade based on Evans classification | Up to 12 weeks |
| Resection rate | Up to 30 weeks |
| R0 resection rate | Up to 30 weeks |
| Intraoperative blood loss | Up to 30 weeks |
| The overall morbidity rates based on Clavien Dindo classification | Up to 50 weeks |
| Number of patient rate in postoperative adjuvant therapy | Up to 30 weeks |
| Dose intensity | Up to 12 weeks |
| Kobe University | Not yet recruiting | Kobe | Hyōgo | Japan |
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| Hyogo College of Medicine | Not yet recruiting | Nishinomiya | Hyōgo | Japan |
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| Nara Medical University | Not yet recruiting | Kashihara | Nara | Japan |
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| Kansai Medical University | Not yet recruiting | Hirakata | Osaka | Japan |
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| Kinki University | Not yet recruiting | Sayama | Osaka | Japan |
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| Osaka University | Not yet recruiting | Suita | Osaka | Japan |
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| Osaka Medical University | Not yet recruiting | Takatsuki | Osaka | Japan |
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| Shiga Medical University | Not yet recruiting | Ōtsu | Shiga | Japan |
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| Chiba University | Not yet recruiting | Chiba | Japan |
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| Gifu University | Not yet recruiting | Gifu | Japan |
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| Hiroshima University | Not yet recruiting | Hiroshima | Japan |
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| Kumamoto University | Not yet recruiting | Kumamoto | Japan |
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| Kyoto Prefectural University of Medicine | Not yet recruiting | Kyoto | Japan |
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| Kyoto University | Not yet recruiting | Kyoto | Japan |
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| Nagoya University | Not yet recruiting | Nagoya, Aichi | Japan |
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| Osaka City University | Not yet recruiting | Osaka | Japan |
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| Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera | Recruiting | Wakayama | 641-8510 | Japan |
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