Unique ID issued by UMIN | UMIN000011993 |
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Receipt number | R000014016 |
Scientific Title | Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer |
Date of disclosure of the study information | 2013/10/09 |
Last modified on | 2021/09/10 15:59:36 |
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Preoperative chemoradiotherapy with irinotecan and S-1 for locally advanced rectal cancer
Japan |
Locally advanced rectal cancer
Locally advanced anal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Radiology |
Malignancy
NO
To evaluate the safety and efficacy of neoadjuvant chemoradiotherapy with S-1 and irinotecan in patients with locally advanced rectal cancer.
Others
To evaluate the predictive value of CD133/COX2 expression and CD8+ lymphocyte aggregation in pretreatment biopsy specimens for tumor regression
pathological Complete Response rate
Predictive value for tumor regression
Relapse free survival (RFS)
Overall survival (OS)
Rate of local recurrence
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1(80mg/m2/day1-5,8-12,22-26,29-33)
irinotecan(80mg/m2/day1,8,22,29)
Radiotherapy(1.8Gy/ 5 times a week for 5 weeks,45Gy/total)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
(1) Rectal or anal cancer whose lower tumor margin is below the peritoneal reflection. The clinical stage is II or III.
(2) Histologically confirmed adenocarcinoma
(3) Without prior anti-tumor therapy
(4) Age:20-80years old
(5) Performance status 0-2
(6) Adequate organ function
WBC>= 4,000 <= 15,000/mm3
neutro>= 2,000/mm3
Plt>= 100,000/mm3
Hb>= 8.0g/dl
Cr<= 1.5mg/dl
T-Bil<= 1.5mg/dl
AST, ALT<= double of the upper limit
(7) Written IC with date
Patients judged inappropriate for this study by the physicians
100
1st name | |
Middle name | |
Last name | Kazuo Hase |
National Defense Medical College
Surgery
3-2 Namiki Tokorozawa Saitama
04-2995-1511
shinto@ndmc.ac.jp
1st name | |
Middle name | |
Last name | Eiji Shinto |
National Defense Medical College
Surgery
3-2 Namiki Tokorozawa Saitama
04-2995-1511
shinto@ndmc.ac.jp
National Defense Medical College
National Defense Medical College
NO
2013 | Year | 10 | Month | 09 | Day |
https://academic.oup.com/bjsopen/article/4/2/301/6061323
Partially published
https://academic.oup.com/bjsopen/article/4/2/301/6061323
49
Main results already published
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 22 | Day |
2011 | Year | 05 | Month | 01 | Day |
2023 | Year | 04 | Month | 30 | Day |
2013 | Year | 10 | Month | 08 | Day |
2021 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014016
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