Unique ID issued by UMIN | UMIN000012857 |
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Receipt number | R000015025 |
Scientific Title | A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III) |
Date of disclosure of the study information | 2014/01/15 |
Last modified on | 2014/01/20 18:16:59 |
A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III)
OITA-trial III
A Phase II trial of sensitivity prediction system of S-1 plus radiation as neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (OITA-trial III)
OITA-trial III
Japan |
locally advanced rectal cancer
Gastroenterology | Radiology |
Malignancy
NO
To evaluate whether OITA-RC-Chip could predict the sensitivity of S-1+radiation as neoadjuvant chemoradiotherapy for patients with locally advanced rectal cancer
Others
sensitivity prediction
Exploratory
Pragmatic
Phase II
predictive value of pathological response
DFS, OS, Response rate, pathological response, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
S-1: 80 mg/m2 p.o. (day1-5, 8-12, 22-26, and 29-33)
Radiation : Total 45Gy/25fr, 1.8Gy/day, on days 1-5, 8-12, 15-19, 22-26, and 29-33).
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Histologically confirmed rectal cancer (Ra, Rb, P)
2) Histologically confirmed adenocarcinoma
3) Within 28 days before registration, Clinical stage T3-4, N0-2(UICC 7th edition)
4) Age of 20 to 80 years old
5) PS(ECOG) 0-1
6) Previously untreated rectal cancer (including chemotherapy, radiotherapy, hormonal therapy, or surgery)
7) be able to take oral drugs
8) Required baseline laboratory parameters (within 14 days before registration):
WBC >= 3000 ,< 12000/mm3
Neu >= 1,500/mm3
Plt >= 100,000/mm3
Hb >= 9.0g/dl
T-Bil <= 2.0mg/dl
AST,ALT <= 100U/L
Cre <1.5mg/dl
Ccr >= 60mL/min
9) Appropriate for the study at the physician's assessment
10) Written informed consent
1) History of serious drug hypersensitivity or a history of drug allergy
2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less)
3) Patients with contraindication to S-1
4) Serious complication ( ex. intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, serious diabetes, serious hypertension cardiac failure, renal failure, or liver failure)
5) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema )
6) Pleural effusion, peritoneal fluid that needs treatment
7) Positive for HBs antigen
8) Patients who have bleeding from GI tract, intestinal paralysis, intestinal obstruction, peptic ulcer
9) Patients who need flucytosine, phenytoin or warfarin potassium.
10) Requiring consecutive systemic administration of steroid drug
11) Pregnant or lactating woman
12) Man who hope for Partner's pregnant
13) High-grade stricture
14) Not appropriate for the study at the physician's assessment
25
1st name | |
Middle name | |
Last name | Masafumi INOMATA |
Oita University faculty of medicine
Department of Gastroenterological and Pediatric Surgery
1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
097-586-5843
geka1@oita-u.ac.jp
1st name | |
Middle name | |
Last name | Masafumi INOMATA |
Oita University faculty of medicine
Department of Gastroenterological and Pediatric Surgery
1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
097-586-5843
geka1@oita-u.ac.jp
Department of Gastroenterological and Pediatric Surgery, Oita University faculty of medicine
None
Self funding
NO
大分大学医学部消化器・小児外科学講座、大分医療センター 外科、大分県立病院 外科、大分赤十字病院 外科、健康保険南海病院 外科、中津市民病院 外科、別府医療センター 外科、九州大学病院別府病院 外科
2014 | Year | 01 | Month | 15 | Day |
Unpublished
Open public recruiting
2013 | Year | 12 | Month | 12 | Day |
2013 | Year | 12 | Month | 12 | Day |
2014 | Year | 01 | Month | 15 | Day |
2014 | Year | 01 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015025
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