The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-

The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study- - The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024323

Enrollment

Registered

2016-10-06

Start date

2016-09-26

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

locally advanced colorectal cancer

Interventions

1) All RAS wild-type: 6 courses of cetuximab+mFOLFOX6 or 4 courses of cetuximab+SOX is performed, followed by curative operarion. 2) All RAS mutant-type: 6 courses of FOLFOXIRI or SOXIRI is performed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) Investigator determines that the appropriate 3) Histologically confirmed colorectal cancer(Excluding the appendix) 4) RAS wild-type or mutant. 5) With measurable lesion 6) Irinotecan case of use UGT1A1 *6 *28 is a wild type or single hetero. 7) Without chemotherapy history (Including the hepatic arterial infusion / radiation therapy). However, with regard to the post-operative adjuvant chemotherapy, to be registered if it passed more than 6 months from the end of treatment. 8) Performance Status (ECOG) 0-2 (Possible outpatient treatment) 9) Age over 20 years 10) Survival period more than 3 months 11) Adequate organ function (Inspection of within 14 days before) 1. WBC: >=3000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T Bil: <=2.0mg/dL 6. AST,ALT: <100IU/L 7. Serum creatinine: <=1.5mg/dL 12) With ability of oral intake

Exclusion criteria

Exclusion criteria: 1) Patients with severe drug allergy (hypersensitivity) 2) Clinical problem infection 3) Liver dysfunction (jaundice) / Severe renal dysfunction 4) Uncontrolled high blood pressure, Diabetes, Hypercalcemia 5) Severe lung disease (Interstitial pneumonia, Pulmonary fibrosis, Advanced emphysema, etc) 6) Patient who need drainage of peritoneal, pleural or pericardial effusion. 7) Brain metastases (Diarrhea a hindrance to daily life in the patient who has a colostomy) 8) Diarrhea (watery stool) 9) Hepatitis B / C virus-positive

Design outcomes

Primary

Measure	Time frame
Response rate (judged by enhanced CT and MRI on 12 weeks after initiation of chemotherapy)	—

Secondary

Measure	Time frame
Induction rate of curative operation, Overall survival, Relapse free survival. Incidence rate of complication	—

Countries

Japan

Contacts

Public ContactKatsuji Tokuhara, MD

Kansai Medical University Medical Center Department of Surgery

tokuhark@takii.kmu.ac.jp06-6992-1001

Outcome results

None listed

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