INSPIRE study

JRCT ID: jRCTs041180118

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Colorectal cancer
• Date of first enrollment: 13/09/2013
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Oxaliplatin based +molecular targeting agents (Pmab, Cmab or Bmab) therapies with antiallergic reaction for metastatic colorectal cancer

Outcome(s)

• Primary Outcome: Progression free survival

Secondary Outcome

Overall survival
Response rate
Allergy
Peripheral neuropathy
Adverse event

Key inclusion & exclusion criteria

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

Include criteria

1)Stage II, III colon cancer patients treated with oxaliplatin based adjuvant chemotherapy. 2)Recurrence after more than 6 months post adjuvant chemotherapy
3)Peripheral neuropathy<=grade1
4)Cumulative dose of oxaliplatin >=more than 300 mg/m2 as adjuvant therapy
5)Measurable lesion by RECIST1.1
6)Age of 20 years or older
7)ECOG Performance status(PS) of 0-1
8)A life expectancy of more than 12 week.
9)No severe impairment of major organs (bone marrow, heart, lungs, liver, kidneys, etc.),
laboratory data within 14 days

WBC <=12,000mm3
neutrophil >=1,500/mm3
hemoglobin >=8.0g/dL
platelet >=100,000/mm3
AST and ALT
<=2.5 ULN or <=5.0 ULN if the patient has liver metastasis
T-Bil <=1.5 ULN
Cr <=UNL
Creatinine clearance >=50 mL/min 10)Written informed consent.

Exclude criteria

1)Serious drug allergy.
2)Serious sensory abnormality or dysfunction
3)Presence of other active malignancies or a history of malignancies within the past 5 years
4)blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days .
5)Uncontrolled pleural effusion, ascites, or pericardial effusion.
6)Clinically significant infection.
7)brain metastasis
8)Clinically significant heart disease (myocardial infarction within 12 months, etc.).
9)Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure )
10)fresh GI bleeding
11)Watery diarrhea
12)Central nervous system disorders
13)Dementia or clinically significant mental/neurological disorders.
14)Women who are pregnant, lactating, or wish to become pregnant.
15)Investigator's judgement.

Related Information

• Primary Sponsor: Mishima Hideyuki
• Source(s) of Monetary Support: Yakult Honsha CO.,Ltd.
• Secondary ID(s): UMIN000011348