Unique ID issued by UMIN | UMIN000039783 |
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Receipt number | R000045372 |
Scientific Title | A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer |
Date of disclosure of the study information | 2020/03/12 |
Last modified on | 2020/03/12 09:42:24 |
A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer
Phase II study of XELOXIRI+Bevacizumab
A phase II trial of oxaliplatin, capecitabine, irinotecan (XELOXIRI) and bevacizumab as first-line therapy for patients with metastatic colorectal cancer
Phase II study of XELOXIRI+Bevacizumab
Japan |
metastatic colorectal cancer
Gastroenterology |
Malignancy
NO
To investigate efficacy and safety of CPT-11 + L-OHP + capecitabine + Bevacizumab therapy for metastatic colorectal cancer
Safety,Efficacy
Exploratory
Phase II
Progression-free survival
Overall survival, response rate, safety, R0 resection rate, efficacy by the RAS mutation status, QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
irinotecan, oxaliplatin, capecitabine, bevacizumab
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1. Histologically confirmed advanced metastatic/recurrent colorectal cancer.
2. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment.
3. Age :20-75 years
4. Wild or hetero type of UGT1A1*28 or *6 genotype
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
6. Vital organ functions (listed below) are preserved within a week prior to entry.
7. Survival more than 3 months.
8. Written informed consent.
1. Need to drain malignant fluid.
2. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium.
3. Pregnant or lactating women or women of childbearing potential.
4. Uncontrolled infection.
5. Evidence of interstinal lung disease, or pulmonary fibrosis.
6. Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction.
7. Uncontrollable ulcer indigestive tract.
8. Radiological evidence of CNS metastases or brain cancer.
9. Complication of cerebrovascular disease or symptoms within 1 year.
10. Any surgical treatments within 4 weeks.
11. Administering antithrombotic drug within 10 days. Need to administrate or having anti-platelets therapy
12. Multiple primary cancers within 5 years.
13. Other conditions not suitable for this study.
47
1st name | Ohnuma |
Middle name | |
Last name | Hiroyuki |
Sapporo Medical University School of Medicine
Department of Medical Oncology
060-0061
S-1, W-16, Chuo-ku, Sapporo
011-611-2111
ohnuma@sapmed.ac.jp
1st name | Ohnuma |
Middle name | |
Last name | Hiroyuki |
Sapporo Medical University School of Medicine
Department of Medical Oncology
060-0061
S-1, W-16, Chuo-ku, Sapporo
011-611-2111
ohnuma@sapmed.ac.jp
Sapporo Medical University School of Medicine
Self funding
Self funding
Clinical trial center, Sapporo Medical University
S-1, W-16, Chuo-ku, Sapporo
011-611-2111
kenkyusien@sapmed.ac.jp
NO
2020 | Year | 03 | Month | 12 | Day |
Unpublished
Open public recruiting
2014 | Year | 11 | Month | 20 | Day |
2014 | Year | 12 | Month | 17 | Day |
2014 | Year | 12 | Month | 22 | Day |
2020 | Year | 12 | Month | 31 | Day |
2020 | Year | 03 | Month | 12 | Day |
2020 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045372
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