Status:
UNKNOWN
Prospective Phase II Randomized Trial of Postoperative Adjuvant Chemotherapy in Patients With High Risk Colon Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Chang Gung Memorial Hospital
Changhua Christian Hospital
Conditions:
Colonic Diseases
Adenocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Based on the astonishing high response rate in metastatic colorectal cancer in weekly high dose 5-FU and leucovorin, we will conduct a clinical trial to clarify the activity of this regimen in the adj...
Detailed Description
Approximately 75% of all patients with colon carcinoma present at a stage when all gross tumor can be surgically resected. Despite that high resectability rate, about 50% of all colon adenocarcinoma p...
Eligibility Criteria
Inclusion
- Signed written informed consent. Curative resection of colon cancer and upper rectal cancer, which is not planned for radiotherapy. Histologically proved adenocarcinoma of the colon. Stages: T1-4N2M0 (LN ≧4) Age less or equal to 70 years old. Performance status: 0 to 1 (ECOG) Adequate liver function (Bil. \< 2 mg/dl, GOT, GPT\< 3x normal limit) Adequate renal function (Cr \< 2.0 mg/dl) Adequate bone marrow function(WBC ≧3500/mm3, Platelet ≧100000/mm3) Individual regular follow-up possible. 3.320 Patient who can receive adjuvant chemotherapy within 6 weeks after operation.
- Patient who can receive a "indwelling catheter" surgery.
Exclusion
- Uncontrolled intercurrent illness, e.g. active infection or concurrent major systemic disease (e.g. psychosis, ESRD, heart failure \[NYHA class III\], liver cirrhosis \[Child B\&C\], or AIDS). Intestinal obstruction or occlusion postoperation. Pregnant or lactating woman. Allergy to 5-Fluorouracil or leucovorin. Other primary cancer except skin squamous or basal cell carcinoma or cured in-situ cancer of the cervix.
- Previous treatment of chemotherapy or radiotherapy.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2012
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00201331
Start Date
April 1 2002
End Date
October 1 2012
Last Update
December 16 2005
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Taiwan, 333