Be TRI

JRCT ID: jRCTs061180021

Registered date:08/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with untreated metastatic colorectal cancer
• Date of first enrollment: 21/05/2015
• Target sample size: 45
• Countries of recruitment: -,Japan
• Study type: Interventional
• Intervention(s): Patients receive 12 cycle of FOLFOXIRI+Bmab therapy (Bmab:5mg/kg, CPT-11:165mg / m 2, L-OHP:85mg/m, l-LV:200mg/m2, Infusional 5-FU:3200mg / m2) every 2 weeks.(Or continue until conflicting with cancellation criteria)

Outcome(s)

• Primary Outcome: Response rate

Secondary Outcome

Time to Treatment Failure
Progression Free Survival
Overall Survival
R0 resection rate
Relative Dose Intensity
Rates of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

1. A case confirmed histopathologically as colorectal cancer
2. Unresectable progressive / recurrent cases
3. Cases with measurable lesions in RECIST 1.1
4. Cases without pretreatment by chemotherapy, immunotherapy or radiotherapy (In case of postoperative adjuvant chemotherapy, it is possible to register after 6 months from the end date of adjuvant chemotherapy.)
5. Cases in which survival of more than 3 months can be expected
6. UGT1A1 * 1 / * 1 (wild group) or UGT1A1 * 6 / * 1, UGT1A1 * 28 / * 1 (heterogroup) was found by genetic polymorphism examination of UGT1A1 * 28 and UGT1A1 * 6 A case
7. Patients with ECOG PS 0 or 1
8. Cases with age of aged acquisition from 20 years to 70 years
9. A case where there is no high degree of disability in the main organ function (bone marrow, liver, kidney, heart, lung etc.) and the laboratory test value performed within 14 days before registration (without including the registration date) satisfies the following criteria
(1) White blood cell count: 3,000 / mm 3 or more to 12,000 / mm 3 or less
(2) Number of neutrophils: 1,500 / mm 3 or more
(3) Platelet count: 100,000 / mm 3 or more
(4) AST: 100 IU / L or less
(5) ALT: 100 IU / L or less
(6) Total bilirubin: 1.5 mg / dL or less
(7) Serum creatinine: 1.50 mg / dL or less
(8) Urinary protein: 1+ or less (qualitative)
(9) Prothrombin time International standard ratio display: 1.5 or less
Inclusion Criteria1. A case confirmed histopathologically as colorectal cancer
2. Unresectable progressive / recurrent cases
3. Cases with measurable lesions in RECIST 1.1
4. Cases without pretreatment by chemotherapy, immunotherapy or radiotherapy (In case of postoperative adjuvant chemotherapy, it is possible to register after 6 months from the end date of adjuvant chemotherapy.)
5. Cases in which survival of more than 3 months can be expected
6. UGT1A1 * 1 / * 1 (wild group) or UGT1A1 * 6 / * 1, UGT1A1 * 28 / * 1 (heterogroup) was found by genetic polymorphism examination of UGT1A1 * 28 and UGT1A1 * 6 A case
7. Patients with ECOG PS 0 or 1
8. Cases with age of aged acquisition from 20 years to 70 years
9. A case where there is no high degree of disability in the main organ function (bone marrow, liver, kidney, heart, lung etc.) and the laboratory test value performed within 14 days before registration (without including the registration date) satisfies the following criteria
(1) White blood cell count: 3,000 / mm 3 or more to 12,000 / mm 3 or less
(2) Number of neutrophils: 1,500 / mm 3 or more
(3) Platelet count: 100,000 / mm 3 or more
(4) AST: 100 IU / L or less *
(5) ALT: 100 IU / L or less *
(6) Total bilirubin: 1.5 mg / dL or less
(7) Serum creatinine: 1.50 mg / dL or less
(8) Urinary protein: 1+ or less (qualitative)
(9) Prothrombin time International standard ratio display: 1.5 or less
10. Regarding the participation of the examination, a case in which the patient's signature, date of consent form has been obtained before the study registration

Exclude criteria

1. Case of insect or carcinoma of the anal canal
2. A case of hematopoietic factor preparation such as blood transfusion, blood preparations and G-CSF administered within 14 days prior to registration
3. Patients with synchronous and non-disease duration of less than 5 years with occasional multiple cancer
4. HBsAg and HCV antibody positive cases
5. Patients with a history of serious drug hypersensitivity
6. Some cases of sensory or dysfunctional
7. A case with extensive history of radiation therapy to the iliac or abdomen
8. Clinical problems with infectious diseases
9. A case of diarrhea (including watery stool)
10. Case with intestinal paralysis or intestinal obstruction
11. Patients with interstitial pneumonia and pulmonary fibrosis
12. A case with pleural effusion, peritoneal fluid, or pericardial effusion requiring treatment
13. A case of administering atazanavir sulfate
14. A case of a heart disease that is clinically problematic on electrocardiogram
15. A case of laparotomy or intestinal resection within 28 days prior to registration, biopsy with stoma formation and incision within 14 days prior to registration
16. A case of brain metastasis that is suspected to have brain metastasis or a clinical diagnosis of brain metastasis
17. Patients with a history of thromboembolism
18. Drugs that inhibit platelet function (such as aspirin or non-steroidal anti-inflammatory drugs)
19. A case with poor control gastrointestinal ulcer
20. Patients with a history of perforation of the digestive tract within the past 12 months
21. Cases with poor control and high blood pressure
22. Cases with poor control diabetes
23. Patients with mental illness or psychiatric symptoms who are considered difficult to participate in the trial
24. Women who are pregnant or nursing, men and women who wish to give birth, men and women who do not intend to conceive
25. A case in which the physician deemed inappropriate by the attending physician to evaluate the efficacy and safety of the trial

Related Information

• Primary Sponsor: Shinozaki Katsunori
• Source(s) of Monetary Support: Yakult Honsha Co.,Ltd.,Yakult Honsha Co.,Ltd.,Yakult Honsha Co.,Ltd.
• Secondary ID(s): UMIN000017102