Unique ID issued by UMIN | UMIN000006523 |
---|---|
Receipt number | R000007733 |
Scientific Title | Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study) |
Date of disclosure of the study information | 2011/10/11 |
Last modified on | 2017/04/18 12:59:16 |
Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)
Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)
Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)
Evaluation of the reintroducing FOLFOX or XELOX +/- BV in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy.(REACT study)
Japan |
Colorectal Cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
To confirm the feasibility and effectiveness of FOLFOX or XELOX +/- BV therapy for recurrent colorectal cancer after more than 6 months post adjuvant chemotherapy including L-OHP(FOLFOX, XELOX, or SOX).
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
response rate
disease control rate
safety
progression free survival
time to treatment failure
overall survival
relative dose intensity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
FOLFOX +/- BV therapy
L-OHP:85mg/m2
5-FU(bolus):400mg/m2
l-LV:200mg/m2
5-FU(infusion):2,400mg/m2
+/- BV:5mg/m2
XELOX +/- BV therapy
L-OHP:130mg/m2
Cape:2,000mg/day
+/- BV:7.5mg/m2
20 | years-old | <= |
Not applicable |
Male and Female
1)Colorectal cancer proven by histology.
2)Past history of adjuvant chemotherapy including L-OHP (FOLFOX, XELOX or SOX) with a cumulative dose of more than 400 mg/m2.
3)Reccernce observed by imaging after more than 6 months post adjuvant chemotherapy.
4)Presence of at least one measurable lesion using the RECIST (ver1.1 guidelines).
5)ECOG Performance status(PS) of 0-2.
6)Age of 20 years or older.
7)Laboratory data within 14 days.
neutrophil >=1,500/mm3
platelet >=100,000/mm3
hemoglobin >=8.0g/dL
Cr <=2.0 UNL
T-Bil <=2.0 ULN
AST and ALT <=2.5 ULN (<=5.0 ULN in case of liver metastasis)
8)Written informed consent.
1)Blood transfusion, administration of hematopoietic factor (human blood products or G-CSF, etc).
2)Serious drug allergy.
3)Peripheral sensory neuropathy >= Grade 2.
4)Active synchronous malignancies.
5)Massive pleural or pericardial
effusion ,or ascites.
6)Infection of clinical issue or fever suspicious of infection.
7)Brain metastasis.
8)Cardiac disease complications (congested heart failure, symptomatic coronary artery disease, uncontrollable cardiac dysrhythmia or history of myocardial infarction within 12 months, etc).
9)Lung disease of clinical issue.
10)Bleeding that requires medication or transfusion.
11)Uncontrolled diarrhea.
12)Ileus or bowel obstruction.
13)Clinically significant mental or psychological disease.
14)Insulin-treated diabetic patients.
15)Women who are pregnant or breast-feeding.
16)Other patients who are unfit for the study as determined by the attending physician.
30
1st name | |
Middle name | |
Last name | Masahito Kotaka |
Sano Hospital
Gastrointestinal Cancer Center
Shimizugaoka 2-5-1, Tarumi-ku, Kobe
078-785-1000
tomomakotaka6410@yahoo.co.jp
1st name | |
Middle name | |
Last name | Masahito Kotaka |
Sano Hospital
Gastrointestinal Cancer Center
Shimizugaoka 2-5-1, Tarumi-ku, Kobe
078-785-1000
tomomakotaka6410@yahoo.co.jp
Hyogo College of Medicine, Department of Surgery
None
Other
NO
2011 | Year | 10 | Month | 11 | Day |
Unpublished
No longer recruiting
2011 | Year | 09 | Month | 05 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 10 | Month | 11 | Day |
2017 | Year | 04 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007733
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |