Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases

Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases - Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003529

Enrollment

Registered

2010-04-26

Start date

2010-04-01

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

locally advanced colorectal cancer with lymph node metastases

Interventions

S-1 80mg/m2/day for 14 days plus L-OHP 100mg/m2 on day 1 every 21 days is administered for 3 course. After treatment, response rate is evaluated. Surgical operation is performed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically confirmed colorectal cancer 2)locally advanced colorectal cancer with lymph node metastases 3)with measurable lesion 4)without ileus 5)without prior chemotherapy 6)without radiation therapy 7)age of 20-80 years 8)Eastern Cooperative Oncology Group performance status (PS) 0-1 9)survival period more than 3 months 10)adequate function of important organs 1. WBC: >=3,000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. AST, ALT: <100IU/L 6. sBil:<=2.0mg/dL 7. sCreatinin: <=1.0mg/dL or creatinine clearance level >= 60ml/min 11)written informed consent 12)with ability of oral intake

Exclusion criteria

Exclusion criteria: 1) with sensory neuropathy 2) with active double cancer 3) had active infection disease (over 38.0 degree) 4) with sever diarrhea 5) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 6) with previous serious drug hyperseneitivity 7) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris) 8) with myelosupression 9) with chickenpox 10) had pleural effusion or ascites which need therapy 11) receiving Flucytosine 12) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant 13) had a previous serious drug allergies 14) .clinical evidence of CNS metastases or had a history of brain metastasis 15) were systemically-administered of steroids 16) with jaundice 17) except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Relapse free survival of 3 years, Overall survival, Resection rate, Safty, Curative resection rate, histological response evaluation	—

Countries

Japan

Contacts

Public ContactYasumasa Takii

Niigata Cancer Center Hospital Department of Surgery

takii@niigata-cc.jp025-266-5111

Outcome results

None listed

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