Unique ID issued by UMIN | UMIN000017793 |
---|---|
Receipt number | R000020613 |
Scientific Title | Prospective observational study of resectability, safety, and efficacy for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment |
Date of disclosure of the study information | 2015/06/04 |
Last modified on | 2018/06/06 11:38:41 |
Prospective observational study of resectability, safety, and efficacy for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment
Prep-04
Prospective observational study of resectability, safety, and efficacy for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment
Prep-04
Japan |
Unresectable pancreatic cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the resectability, safety, and efficacy of adjuvant surgery for initially unresectable pancreatic cancer responding to anti-cancer treatment
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Resection rate
Mortality, Morbidity, Survival, Recurrence, Tumor marker kinetics
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Initially diagnosed as unresectable pancreatic cancer
2. Anti-cancer treatment (chemotherapy and/or radiotherapy etc) over 3 months before surgery
3. Obtained disease control by anti-cancer treatment
4. Planned surgery with informed consent
5. Tolerable for curative surgery
6. Written informed consent for the study
1. Under 20 year old at entry
2. Initially resectable
3. Anti-cancer treatment within 3 months before surgery
4. Disease progression at entry
5. Not planned surgery
6. Intolerable for curative surgery
7. Recurrent pancreatic cancer
100
1st name | |
Middle name | |
Last name | Michiaki Unno |
Tohoku University
Surgery
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
022-717-7205
m_unno@surg1.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Fuyuhiko Motoi |
Tohoku University
Surgery
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
022-717-7205
http://www.surg1.med.tohoku.ac.jp/society/index.html
fmotoi@surg1.med.tohoku.ac.jp
Study Group of Preoperative therapy for Pancreatic Cancer (Prep)
Study Group of Preoperative therapy for Pancreatic Cancer (Prep)
Self funding
Japan
NO
2015 | Year | 06 | Month | 04 | Day |
http://www.surg.med.tohoku.ac.jp/surg1/society/prep04_siken.html
Unpublished
No longer recruiting
2015 | Year | 02 | Month | 04 | Day |
2015 | Year | 06 | Month | 04 | Day |
Initially unresectable pancreatic cancer has dismal prognosis with median 8 to 15 months for locally advanced or with median 8 to 12 months for metastatic disease even after chemotherapy or chemoradiotherapy. Despite improvement of recent treatment, long-term survival is rarely obtained. Project study of JHPBS-01 revealed that adjuvant surgery improved overall survival for initially unresectable pancreatic cancer treated over 6 months. Some other reports also showed the prolonged survival by adjuvant surgery, however, the indication, resectability, safety, and efficacy of adjuvant surgery was not fully elucidated.
This study is prospective observation for adjuvant surgery against initially unresectable pancreatic cancer responding to anti-cancer treatment to evaluate the resectability, safety, and efficacy by enrollment before surgery.
2015 | Year | 06 | Month | 03 | Day |
2018 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020613
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |