Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO)

Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO) - Randomized phase II study of adding steroid for prevention of venous pain in CRC patients who are receiving oxaliplatin through peripheral vein (APOLLO)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004286

Enrollment

Registered

2010-10-01

Start date

2010-09-15

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

XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Oxaliplatin is combined with dexamethasone (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histopathologically confirmed colorectal cancer. 2)Chemotherapy-naive patients. Adjuvant chemotherapy by fluoropyrimidine alone is eligible. 3)Measurable lesion by RECIST 4)Oxaliplatin administration by peripheral vein. 5)Not receiving analgesic treatment. 6) ECOG Performance status(PS) of 0-1 7)age of 20 years or older. 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 >=3,000/mm3 and <=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)Neuropathy or sensory dysfunction. 3)Pain in the arm. 4)Current analgesic treatment. 5)Active double cancer within the past 5 years. 6)Serious psychological disease. 7)Steroid treatment. 8)blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days . 9)Pleural effusion, ascites, or pericardial effusion. 10)Clinically significant infection. 11)brain metastasis 12)Clinically significant heart disease (myocardial infarction within 12 months, etc.). 13)Clinically significant pulmonary disease 14)bleeding that requires medication or transfusion. 15)Watery diarrhea. 16)Ileus or bowel obstruction. 17)Central nervous system disorders. 18)Dementia or clinically significant mental/neurological disorders. 20)Investigator's judgement.

Design outcomes

Primary

Measure	Time frame
The incidence of venous pain:Grade>=2	—

Secondary

Measure	Time frame
1)time to occurrence of venous pain 2)adverse events 3)response rate 4)time to treatment failure 5)overall survival	—

Countries

Japan

Contacts

Public ContactChigusa Abe

Epidemiological and Clinical research Information Network (ECRIN) Data Center

chigusa.abe@ecrin.or.jp075-762-1227

Outcome results

None listed

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