SOAC1701

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: JPRN-jRCTs031180382
• Lead Sponsor: Matsubara Hisahiro

Brief Summary

The patients were enrolled from August 2019 to August 2020 from two centers. TAS-102+Bevacizumab as 2nd line treatment for patients with unresectable colorectal cancer who were 1: 20-74 years old and PS2, 2: 75 years old or older and PS0 or 1, 3: 20 years old or older and refractory or intolerant to irinotecan and oxaliplatin. The decision was made to discontinue the study on November 1, 2021 due to insufficient number of enrolled patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2021-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7

Inclusion 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 =8) gave written informed consent

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival

Secondary Outcome Measures

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