SOAC1701

JRCT ID: jRCTs031180382

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 03/09/2019
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Repeat administration until the following regimen falls into the 28 days as one course and falls under the criteria for discontinuation of study treatment.
TAS - 102 is administered for 2 consecutive days after a continuous oral administration for 5 days twice a day after dinner and meal, with the prescribed dosage adjusted to body surface area. Repeat this 2 times and then take a rest for 14 days. Repeat administration with this as a course. Incidentally, weight reduction is made according to the condition of the patient.
Infusing Bevacizumab intravenously over the course of 90 minutes on Day 1, Day 15.

Outcome(s)

• Primary Outcome: Progression Free Survival

Secondary Outcome

1)Overall Survival
2)Time to Treatment Failure
3)Response Rate
4)Disease control rate
5)Adverse events
6)Relation between RAS status and effectiveness of chemotherapy
7)Relation between location of tumor and effectiveness of chemotherapy
8)Relation between the timing when chemotherapy started and effectiveness of chemotherapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) patient with any of the fllowing
(1) patient who is 20 years or older, and considered to be intorelant to irinotecan or oxaliplatin.
(2) Patient who is 20 to 74 years old and with an ECOG Performance Status of 2
(3) Patient who is over 75 years old and with an ECOG Performance Status of 0 or 1
2) patient who has histologically or cytologically confirmed colorectal adenocarcinoma
3) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
4) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them
5) patient who has at least one measurable lesion in imaging study
6) patient with ability to tolerate oral drug administration
7) patient who has adequate main organ functions in tests within 14 days before enrollment
(1) WBC >= 3500/mm3
(2) neutrophil count >=1,500/mm3
(3) platelet count >=75,000/mm3
(4) haemoglobin concentorarion >=9.0 g/dL
(5) AST, ALT <= 2.5x Upper limit of normal (<= 5.0x when liver metastasis exists)
(6) serum total bilirubin level <=1.5 mg/dL (<= 2.0 when liver metastasis exists)
(7) serum creatinine <=1.5 mg/dL
(8) no active infection
(9) Peripheral neuropathy<=grade2
(10) Diarrhea and NonHaematotoxicity =<grade1
8) gave written informed consent

Exclude criteria

1) contraindications for TAS-102 and BEvacizumab
2) previously received chemotherapy with TAS-102
3) severe drug allergy
4) pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy.
5) patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.)
6) have pleural effusion and ascitic fluid with the treatment
7) previous hemoptysis (over 25ml of fresh blood)
8) current or previous (within the last 6 months) history of GI perforation
9) patient with thrombosis (within the last 6 months)
10) patient with bleeding tendency
11) synchronous or metachronous multiple malignancy within the last 5 year disease free interval
12) dicision of unsuitable for this study by the investigator

Related Information

• Primary Sponsor: Matsubara Hisahiro
• Secondary ID(s): UMIN000031790