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

UMIN ID: UMIN000001698

Registered date:10/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: locally advanced colorectal cancer with lymph node metastases
• Date of first enrollment: 2005/09/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Relapse free survival of 3 years Overall survival Resection rate Safty Curative resection rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
• Secondary Sponsor: Niigata Colorectal cancer Chemotherapy Study Group
• Source(s) of Monetary Support: None