Unique ID issued by UMIN | UMIN000007834 |
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Receipt number | R000008819 |
Scientific Title | A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer |
Date of disclosure of the study information | 2012/05/11 |
Last modified on | 2019/01/07 16:58:31 |
A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer
A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer
(TRICOLORE)
A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer
A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer
(TRICOLORE)
Japan |
unresectable or recurrent colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the non-inferiority and superiority of TS-1/irinotecan + bevacizumab therapy against 5-FU/l-LV/oxaliplatin(mFOLFOX6) + bevacizumab therary or capecitabine/oxaliplatin(CapeOX) + bevacizumab therapy in progression free survival for unresectable advanced/recurrent colorectal cancer
Safety,Efficacy
Phase III
Progression free survival(PFS)
Overall survival(OS)
Response rate(RR)
Time to treatment failure(TTF)
Relative dose intensity(RDI)
Safety
Quality of life(QOL)
Quality adjusted life years(QALY)
Health economics
Translational research
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
arm A-1:mFOLFOX6+Bevacizumab
Bevacizumab 5mg/kg/bi-week
L-OHP 85mg/m2/bi-week
l-LV 200mg/m2/bi-week
5-FU/bolus 400mg/m2/bi-week
5-FU/infusional 2,400mg/m2/bi-week
arm A-2: CapeOX+Bevacizumab
Bevacizumab 7.5mg/kg/tri-week
L-OHP 130mg/m2/tri-week
Capecitabine 1200-2100mg/twice/day(day 1-15)
arm B-1:TS-1/CPT-11+Bevacizumab(SIRB)
Bevacizumab 7.5mg/kg/tri-week
CPT-11 150mg/m2/tri-week
S-1 40-60mg/twice/day(day1-15)/tri-week
arm B-2:TS-1/CPT-11+Bevacizumab(IRIS/BV)
Bevacizumab 5mg/kg/(day1and15)/4-weeks
CPT-11 100mg/m2/(day1and15)/4-weeks
S-1 40-60mg/twice/day(day1-15)/4weeks
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically proven colorectal cancer (Adenocarcinoma)
2.Unresectable advanced/recurrent colorectal cancer
3.Aged over 20 years at the time of registration
4.Performance status(ECOG) :0,1
5.Patients with evaluable lesion
6.Previously not treated (chemotherapy, radiotherapy, etc.) for unresectable colorectal cancer
7.Able to receive oral treatment
8.Adequate organ function
9.Life expectancy estimated>=3 months
10.Written IC
1.History of serious drug hypersensitivity
2.Pregnant, lactating or women of
child-bearing potential. Men who want get partner pregnant.
3.Active infections
4.Serious complications
5.Significant abnormal ECG or history of cardiovascular disease
6.Peptic ulcers
7.Peripheral neuropathy
8.Watery diarrhea
9.Massive pleural effusion or ascites
10.Mechanical bowel obstruction
11.Symptomatic peritoneum dissemination
12.Brain metastasis
13.Current or previous (within the last 6 months) history of GI perforation
14.Hemoptysis (=> 2.5ml)
15.Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
16.Any surgical treatments within 28 days
17.Evidence of bleeding diathesis or coagulopathy
18.Ongoing treatment with anticoagulant or aspirin (> 325mg/day)
19.Administering transfusion within 14 days
20.Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
21.Under coutinuous steroid administration
22.Active hepatitis type HBs positive
23.Administration contraindication of 5-FU, Leucovorin, Capecitabine, TS-1, Oxaliplatin, CPT-11 and Bevacizumab
24.Any other cases who are regarded as inadequate for study enrollment by the investigator
450
1st name | |
Middle name | |
Last name | Chikashi Ishioka(1), Yoshito Komatsu(2), Ken Shimada(3), Tatsuro Yamaguchi (4) |
Institute of Development, Aging and Cancer, Tohoku University(1)
Hokkaido University Hospital(2)
Showa University Kouto Toyosu Hospital(3)
Komagome Hospital(4)
Department of Clinical Oncology (1), Cancer Center (2), Department of Medical Oncology (3), Department of Surgery,Hereditary Tumor Research Project(4)
4-1 Seiryo-cho Aoba-ku Sendai Miyagi (1), N14 W5 Kita-ku Sapporo Hokkaido (2), 5-1-38 Toyosu,Kouto-ku (3), 3-18-22 Honkomagome, Bunkyo-ku, Tokyo (4)
03-5401-5020
tricolore@tcog.jp
1st name | |
Middle name | |
Last name | TRICOLORE study affairs office |
The Tokyo Cooperative Oncology Group
Clinical Study Promotion Agency
2-1-18 Hamamatsu-cho Minato-ku Tokyo
03-5401-5020
tricolore@tcog.jp
The Tokyo Cooperative Oncology Group
TAIHO PHARMACEUTICAL CO.,LTD
Profit organization
NO
2012 | Year | 05 | Month | 11 | Day |
Partially published
https://academic.oup.com/annonc/advance-article/doi/10.1093/annonc/mdx816/4779925
Completed
2012 | Year | 04 | Month | 13 | Day |
2012 | Year | 06 | Month | 01 | Day |
2019 | Year | 02 | Month | 28 | Day |
2012 | Year | 04 | Month | 25 | Day |
2019 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008819
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