UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of FOLFOXIRI + Bevacizumab in patients with untreated metastatic colorectal cancer
Acronym	Bevacizumab + Triplet treatment for untreated metastatic colorectal cancer
Scientific Title	Phase II trial of FOLFOXIRI + Bevacizumab in patients with untreated metastatic colorectal cancer
Scientific Title:Acronym	Bevacizumab + Triplet treatment for untreated metastatic colorectal cancer
Region	Japan

Condition
Condition	Patients with metastatic colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of FOLFOXIRI + bevacizumab in untreated metastatic colorectal cancer patients who harbor UGT1A1*1/*1, *1/*6 or *1/*28.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Time to treatment failure Progression-free survival Overall survival R0 resection rate Relative dose intensity Incidence of adverse events Early tumor shrinkage Deepness of response

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients receive FOLFOXIRI plus bevacizumab [L-OHP: 85 mg/sq.m., CPT-11: 165 mg/sq.m., 5-FU(c.i.v.): 3,200 mg/sq.m., l-LV: 200 mg/sq.m., bevacizumab: 5 mg/kg]. The treatment will be repeated every 2 weeks, for up to 12 cycles, unless the disease progression, unacceptable toxicity, tumor resection or consent withdrawal.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed adenocarcinoma of the colon or rectum. 2. Unresectable or recurrent colorectal cancer patient. 3. One or more measurable lesion in RECIST ver.1.1 criteria. 4. No prior chemotherapy, immunotherapy, and radiotherapy. 5. Life expectancy at least 3 months. 6. Patients who harbor UGT1A1*1/*1, *1/*6 or *1/*28. 7. ECOG performance status of =<1. 8. Vital organ functions (listed below) are preserved within 14 days prior to entry. WBC: >= 3,000 per cubic millimeter Neu: >= 1,500 per cubic millimeter PLT: >= 100,000 per cubic millimeter AST and ALT: <= 100 IU/L , <= 150 IU/L in cases with liver metastasis T-bil: <= 2.0 mg/dL Serum creatinine: <= 1.50 mg/dL Proteinuria: <= 1+ PT-INR: < 1.5 9. Written informed consent.
Key exclusion criteria	1. Vermiform appendix cancer and proctos cancer. 2. Administration of blood products/ G-CSF, and blood transfusion within 14 days. 3. Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. 4. HBs-Ag(+), or HCV-Ab(+). 5. History of severe allergy. 6. Sensory alteration or paresthesia interfering with function. 7. Prior radiotherapy for ilium and abdomen. 8. Infectious disease. 9. Uncontrolled diarrhea. 10. Ileus or bowel obstruction. 11. Interstitial lung disease or pulmonary fibrosis. 12. Malignant coelomic fluid required drainage. 13. Administration of atazanavir sulfate. 14. Heart disease to be clinically problem. 15. Major surgical procedure or intestinal resection within 28 days prior to enrollment or colostomy within 14 days prior to enrollment. 16. Known brain metastasis or strongly suspected of brain metastasis. 17. History of a thromboembolic disease. 18. Receiving anti-platelet drugs. 19. Poorly controlled gastrointestinal ulcer. 20. History of intestinal perforation within 12 months. 21. Poorly controlled hypertension. 22. Poorly controlled diabetes mellitus. 23. Severe mental disorders. 24. Women's pregnant or nursing, men/women who want to give birth or no intention to contraception. 25. Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsunori Shinozaki, Tomohiro Nishina
Organization	Hiroshima Prefectural Hospital, National Hospital Organization Shikoku Cancer Center
Division name	Division of Clinical Oncology, Department of Gastrointestinal Medical Oncology
Zip code
Address	1-5-54, Ujina-kanda, Minami-ku, Hiroshima, 734-8530, Kou 160 Minamiumemotomachi, Matsuyama, Ehime 791-0280
TEL	082-254-1818
Email	k-shinozaki@hph.pref.hiroshima.jp

Public contact
Name of contact person	1st name Middle name Last name Masami Yamauchi
Organization	Hiroshima Prefectural Hospital
Division name	Division of Clinical Oncology
Zip code
Address	1-5-54, Ujina-kanda, Minami-ku, Hiroshima, 734-8530
TEL	082-254-1818
Homepage URL
Email	mt.28@nifty.com

Sponsor
Institute	Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Institute
Department

Funding Source
Organization	Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 20 Day
Date of IRB	2015 Year 03 Month 20 Day
Anticipated trial start date	2015 Year 04 Month 19 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 04 Month 11 Day
Last modified on	2020 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019805