Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant

Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant - INSPIRE study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011348

Enrollment

Registered

2013-08-01

Start date

2013-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Oxaliplatin fluoropyrimidine molecularly targeted drug

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival Response rate Allergy Peripheral neuropathy Adverse event	—

Countries

Japan

Contacts

Public ContactYumi Miyashita

Epidemiological and Clinical research Information Network (ECRIN) Aichi branch

miya@ecrin.or.jp0564-64-7300

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026