Unique ID issued by UMIN | UMIN000003164 |
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Receipt number | R000003837 |
Scientific Title | A feasibility study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the patient with advanced colorectal cancer |
Date of disclosure of the study information | 2010/02/11 |
Last modified on | 2016/07/07 19:18:21 |
A feasibility study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the patient with advanced colorectal cancer
A feasibility study of adjuvant XELOX therapy for the patient with advanced colorectal cancer
A feasibility study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the patient with advanced colorectal cancer
A feasibility study of adjuvant XELOX therapy for the patient with advanced colorectal cancer
Japan |
Colorectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
To confirm the feasibilitiy and safety of adjuvant treatment with a combination of capecitabine plus oxaliplatin for the patient with colorectal cancer
Safety
Exploratory
Not applicable
Patients ratio with completion of adjuvant XELOX therapy
Adverse events, severe adverse events, dose intensity, recurrence free survival, and overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Adjuvant chemotherapy with capecitabine plus oxaliplatin
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically proved adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of colon or rectum.
2) Stage IIIA/IIIB (Japanese classification), or P1, or M1(LYM)
3) >=D2 lymph node dissection
4) Pathological curability is A or B
5) Age between 20 and 75 years
6) ECOG performance status 0-1
7) No prior chemotherapy or radiotherapy
8) Enough oral food and drug intake possible
9) Adequate organ function
10) Able to start between 4 and 6 weeks after surgery
11) Written informed consent
1) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2) Pregnant or breast-feeding women
3) Severe mental disease
4) Systemic administration of corticosteroids
5) Continuous medication of flusitosine, fenitoin,and/or Warfarin
6) Other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
7) Myocardial infarction within the past 6 months
8) Inadequate physical condition, as diagnosed by primary physician
25
1st name | |
Middle name | |
Last name | Daisuke Sakai |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Team for colorectal cancer
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
1st name | |
Middle name | |
Last name | Daisuke Sakai |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Medical Oncology
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka Medical Center for Cancer and Cardiovascular Diseases
Self funding
NO
2010 | Year | 02 | Month | 11 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/25743138
Completed
2009 | Year | 10 | Month | 01 | Day |
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 02 | Month | 10 | Day |
2016 | Year | 07 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003837
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