Observational study of hand-foot syndrome events from XELOX therapy for metastatic colorectal cancer.

Observational study of hand-foot syndrome events from XELOX therapy for metastatic colorectal cancer. - The study of metastatic colorectal cancer to investigate impact of learning effect.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007185

Enrollment

100

Registered

2012-02-01

Start date

2011-04-01

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

metastatic colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Writen informed consent 2. Histological confirmation of colorectal cancer 3. Age: 20-80 years 4. Performance status (PS) 0-1 5. With first line treatment for metastatic colorectal canncer 6. Adequate organ function within 14 days before registration Wbc >= 3000 (Neu >=1,500/ mm3) Plt >= 100,000/ mm3 Hb >= 9.0g/dl T-bil 1.5 times of normal range in each institute AST, ALT and ALP =< 2.5xULN IU/L (5.0xULN IU/L in case of liver metastasis) scre =< 1.5xULN mg/dl

Exclusion criteria

Exclusion criteria: 1.Pleural effusion, peritoneal fluid and pericardial fluid. 2. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 3. Serious drug hypersensitivity or a history of drug allergy for Fluorouracil, leucovorin calcium or platinum agents. 4. Dihydropyrimidine Dehydrogenase Deficiency. 5. Evidence of interstinal lung disease, or pulmonary fibrosis. 6. Uncontrolled Active infection. 7. Difficulty on oral intake. 8. Other conditions not suitable for this study 9. Symptomatic brain metastasis. 10. Complication of cerebrovascular disease or symptoms within 1 year. 11. Any surgical treatments including skin open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 12. Planned surgery during this study. 13. Administering antithrombotic drug within 10 days. 14. Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDs). 15. Evidence of bleeding diathesis or coagulopathy. 16. Active gastrointestinal ulcer. 17. Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry. 18. Uncontrolled Hypertension. 19. Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction

Design outcomes

Primary

Measure	Time frame
HFS (> grade 2) events rate for classification of Blum	—

Secondary

Measure	Time frame
Evaluation of QOL: 1) HADS (Hospital Anxiety and Depression Scale) 2)MAC (Mental Adjustment to Cancer)	—

Countries

Japan

Contacts

Public ContactHiroshi Matsuoka

Fujita Health University Gastrointestinal Surgery

0562-93-9296

Outcome results