Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer.
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|ClinicalTrials.gov Identifier: NCT02506803|
Recruitment Status : Unknown
Verified May 2016 by Hiroki Yamaue, Wakayama Medical University.
Recruitment status was: Recruiting
First Posted : July 23, 2015
Last Update Posted : May 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: NAC-GEMABR||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Neoadjuvant Chemotherapy of Gemcitabine Plus Nab-paclitaxel for Patients With Borderline Resectable Pancreatic Cancer.|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Neoadjuvant chemotherapy 2 courses of NAC-GEMABR for subsequent 10 patients.
NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.
Other Name: Gemcitabine, nab-paclitaxel
- Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 30 weeks. ]Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
- The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 24 weeks ]
- The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 30 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506803
|Contact: Hiroki Yamaue, M.D., PhD||+81-73-441-0613 ext firstname.lastname@example.org|
|Wakayama Medical University||Recruiting|
|Wakayama, Japan, 641-8510|
|Principal Investigator: Hiroki Yamaue, M.D., PhD|
|Sub-Investigator: Ken-ichi Okada, M.D., PhD|
|Sub-Investigator: Manabu Kawai, M.D., PhD|
|Sub-Investigator: Seiko Hirono, M.D., PhD|
|Sub-Investigator: Motoki Miyazawa, M.D., PhD|
|Sub-Investigator: Atsushi Shimizu, M.D., PhD|
|Sub-Investigator: Yuji Kitahata, M.D., PhD|
|Principal Investigator:||Hiroki Yamaue, M.D., PhD||Wakayama Medical University|