Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases.

Phase II study of neoadjuvant chemotherapy with CPT-11 and S-1 for locally advanced colorectal cancer with lymph node metastases. - Phase II study of neoadjuvant chemotherapy with CPT-11 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-UMIN000001698

Enrollment

Registered

2009-02-10

Start date

2005-09-01

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 CPT-11 100mg/m2 on day 1 and 15 every 28 days is administered for 2 course. After treatment, response rate is evaluated. Surgical operation is performed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)colorectal cancer proven histologically 2)locally advanced colorectal cancer with lymph node metastases 3)with measurable lesion at primary tumor 4)without ileus 5)without prior chemotherapy 6)without radiation therapy 7)age 20-80 years patients 8)Eastern Cooperative Oncology performance status (PS) 0-1 9)survival period more than 3 months 10)sufficient function og important organs a. WBC: >=4,000/mm3 and 12,000/mm3 b. Neutrophil: >=2,000/mm3 c. Platelet: >=100,000/mm3 d. Hemoglobin: >=9.0g/dL e. AST, ALT: <100IU/L f. sT. bil:<=1.5mg/dL g. sCreatinin: <=1.2mg/dL h. nomal ECG 11)written informed consent 12)with ability of oral intake

Exclusion criteria

Exclusion criteria: 1)with serious interstitial lung fibrosis 2)with active double cancer 3)with active infection ,intestinal paralysis or ileus 4)with water solubility diarrhea 5)with uncontrolled diabetes mellitus 6)with serious complication (e.g. heart failure, hepatic failure, kidney failure) 7)receiving Flucytosine 8)pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 9with previous serious medical illness or allergy for drugs 10)with brain metastasis or treated for brain metastasis 11)with myelosupression 12)with pleural effusion or abdominal dropsy 13)with jaundice 14)receiving steroids 15)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	—

Countries

Japan

Contacts

Public ContactYasumasa Takii

Niigata Cancer Center Hospital Surgery

takii@niigata-cc.jp025-266-5111

Outcome results

None listed

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