Unique ID issued by UMIN | UMIN000024323 |
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Receipt number | R000027398 |
Scientific Title | The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study- |
Date of disclosure of the study information | 2016/10/06 |
Last modified on | 2016/10/06 20:29:47 |
The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-
The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-
The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-
The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-
Japan |
locally advanced colorectal cancer
Gastrointestinal surgery |
Malignancy
NO
To assess the efficacy and the safety of first line chemotherapy for locally advanced colorectal cancer with RAS wild and mutation type.
Efficacy
Phase II
Response rate (judged by enhanced CT and MRI on 12 weeks after initiation of chemotherapy)
Induction rate of curative operation, Overall survival, Relapse free survival. Incidence rate of complication
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
1) All RAS wild-type: 6 courses of cetuximab+mFOLFOX6 or 4 courses of cetuximab+SOX is performed, followed by curative operarion.
2) All RAS mutant-type: 6 courses of FOLFOXIRI or SOXIRI is performed, followed by curative operation.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Written informed consent
2) Investigator determines that the appropriate
3) Histologically confirmed colorectal cancer(Excluding the appendix)
4) RAS wild-type or mutant.
5) With measurable lesion
6) Irinotecan case of use UGT1A1 *6 *28 is a wild type or single hetero.
7) Without chemotherapy history (Including the hepatic arterial infusion / radiation therapy). However, with regard to the post-operative adjuvant chemotherapy, to be registered if it passed more than 6 months from the end of treatment.
8) Performance Status (ECOG) 0-2 (Possible outpatient treatment)
9) Age over 20 years
10) Survival period more than 3 months
11) Adequate organ function (Inspection of within 14 days before)
1. WBC: >=3000/mm3 and 12,000/mm3
2. Neutrophil: >=1,500/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T Bil: <=2.0mg/dL
6. AST,ALT: <100IU/L
7. Serum creatinine: <=1.5mg/dL
12) With ability of oral intake
1) Patients with severe drug allergy (hypersensitivity)
2) Clinical problem infection
3) Liver dysfunction (jaundice) / Severe renal dysfunction
4) Uncontrolled high blood pressure, Diabetes, Hypercalcemia
5) Severe lung disease (Interstitial pneumonia, Pulmonary fibrosis, Advanced emphysema, etc)
6) Patient who need drainage of peritoneal, pleural or pericardial effusion.
7) Brain metastases (Diarrhea a hindrance to daily life in the patient who has a colostomy)
8) Diarrhea (watery stool)
9) Hepatitis B / C virus-positive
35
1st name | |
Middle name | |
Last name | Katsuji Tokuhara, MD |
Kansai Medical University Medical Center
Department of Surgery
10-15 Fumizono-cho, Moriguchi Osaka, 570-8507, Japan
06-6992-1001
tokuhark@takii.kmu.ac.jp
1st name | |
Middle name | |
Last name | Katsuji Tokuhara, MD |
Kansai Medical University Medical Center
Department of Surgery
10-15 Fumizono-cho, Moriguchi Osaka, 570-8507, Japan
06-6992-1001
tokuhark@takii.kmu.ac.jp
Kansai Medical University Medical Center
none
Other
NO
2016 | Year | 10 | Month | 06 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 09 | Month | 26 | Day |
2016 | Year | 09 | Month | 26 | Day |
2016 | Year | 10 | Month | 06 | Day |
2016 | Year | 10 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027398
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