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

Conditions

unresectable or recurrent colorectal cancer

Satoshi Yuki, Makio Gamoh, Tadamichi Denda, Atsuo Takashima, Shin Takahashi et al. (20 authors)

Journal of Clinical Oncology2020-02-015 citations

10.1200/jco.2020.38.4_suppl.169

Updated analysis and exploratory analysis of primary tumor location in the TRICOLORE trial: A randomized phase III trial of S-1 and irinotecan plus bevacizumab versus mFOLFOX6 or CapeOX plus bevacizumab as first-line treatment for metastatic colorectal cancer

Masato Nakamura, Atsuo Takashima, Tadamichi Denda, Makio Gamoh, Ichiro Iwanaga et al. (20 authors)

Annals of Oncology2018-10-01

10.1093/annonc/mdy281.023

S-1 and irinotecan plus bevacizumab versus mFOLFOX6 or CapeOX plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer (TRICOLORE): a randomized, open-label, phase III, noninferiority trial.

Yamada Y, Denda T, Gamoh M, Iwanaga I, Yuki S, Shimodaira H, Nakamura M, Yamaguchi T, Ohori H, Kobayashi K, Tsuda M, Kobayashi Y, Miyamoto Y, Kotake M, Shimada K, Sato A, Morita S, Takahashi S, Komatsu Y, Ishioka C.

2018-03-0170 citations

10.1093/annonc/mdx816

Microbiological and Clinical Effects of Sitafloxacin and Azithromycin in Periodontitis Patients Receiving Supportive Periodontal Therapy

Takako Eguchi Nakajima, Takafumi Okui, H. Ito, Mayuka Nakajima, Tomoyuki Honda et al. (9 authors)

Antimicrobial Agents and Chemotherapy2016-01-0516 citations

10.1128/aac.02575-15

Study protocol of the TRICOLORE trial: a randomized phase III study of oxaliplatin-based chemotherapy versus combination chemotherapy with S-1, irinotecan, and bevacizumab as first-line therapy for metastatic colorectal cancer

Yoshito Komatsu, Chikashi Ishioka, Ken Shimada, Yasuhide Yamada, Makio Gamoh et al. (12 authors)

BMC Cancer2015-09-0914 citations

10.1186/s12885-015-1630-1

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Progression free survival(PFS)	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Outcome results

None listed