Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer

Evaluation for effects on anticancer efficacy and patient's QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer - Evaluation for effects from dosage adjustment caused by skin toxicity in Panitumumab treatment for metastatic colorectal cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015065

Enrollment

Registered

2014-09-05

Start date

2014-06-16

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

mFOLFOX6+Panitumumab therapy is performed until PD. And dosage of Panitumumab is adjusted according to skin toxicity measured by self-check sheet before each therapy. Oxaliplatin 85mg/m2 5FU 400mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proved colorectal cancer (adenocarcinoma) 2. Unresectable advanced or recurrent colorectal cancer 3. KRAS wild type 4. Anticancer drug-naive when consent gained 5. ECOG performance status of 0-2 6. Measureable region evaluable according to the RECIST of CT or MRI 7. Life expectancy of at least 2 months 8. Major organ function within 2 weeks of enrollment have met the following criteria. (1) WBC >= 3,000/mm3 and WBC < 12,000/mm3 (2) Neutrophil >= 1,500/mm3 (3) Platelet >= 100,000/mm3 (4) Hemoglobin concentration >= 8.0g/dL (5) AST and ALT <= 100IU/L (6) Total bilirubin <= 2.0mg/dL (7) Ccr >= 50mL/min or serum creatinine < 1.2mg/dL Without measurement to use Cockcroft-Gault Ccr=[(140-age)*body weight]/(72*serum creatinine)(if female *0.85) 9. Written consent of the patient has been obtained

Exclusion criteria

Exclusion criteria: 1. Presence of severe drug allergy 2. Administration contraindication of using drugs 3. Antiplatelet or anticoagulant cannot be discontinued 4. Active infectious disease causing fever more than 38 deg C 5. Active gastrointestinal bleeding 6. Serious comorbidities (ileus, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, severe renal failure and liver failure etc.) 7. Pleural effusion or ascites that drainage is needed for 8. Other active malignancies those DFS is within 5 years (except for carcinoma in situ that was confirmed cured by local treatment) 9. Women of childbearing potential, women in pregnancy or lactation and patients who have desire to bear children 10. Investigator deems inappropriate to participate in the test

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Quality of life of the patient, response rate, total dosage and duration of Panitumumab	—

Countries

Japan

Contacts

Public ContactHiroyasu Iwasaki

Gifu Prefectual Tajimi Hospital gastroenterology

iwasaki-hiroyasu@tajimi-hospital.jp0572-22-5311

Outcome results

None listed

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

Evaluation for effects on anticancer efficacy and patient&#39;s QOL from dosage adjustment caused by skin toxicity in Panitumumab treatment for Metastatic Colorectal Cancer