Association of MSI, TS, DPD, MVD and EGFR With Chemosensitivity in Stage IV in Colorectal Cancer
Recruitment status was Active, not recruiting
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Purpose
The present project will follow our previous phaseⅡ study of FOLFOX regimens for the treatment of stage Ⅳ colorectal cancer. We will recruit at least 200 patients for this study. The selection of patients will be based on rigorous eligibility criteria. The patients will be allocated based on the expression of each molecular marker (MSI, TS, DPD, MVD and EGFR) and the implementation of chemotherapy. For example, in the examination for the clinical implications of EGFR, the patients will be classified into four groups: EGFR（＋） chemotherapy（＋）; EGFR（＋） chemotherapy（－）; EGFR（－） chemotherapy（＋）; EGFR（－） chemotherapy（－）. Base on the analysis of this 2×2 table, we will clarify the prognostic significance of a specific molecular marker is due to whether the specific molecular marker predicts biological invasiveness and/or chemosensitivity. We believe the present study will have the following significance: （1）To further clarify the mechanisms for the carcinogenesis and progression of CRC; （2）To facilitate the development of novel chemotherapeutic agents; and （3） To gain the experience for the practice of evidence-based medicine.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Chemotherapy |
Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Association of MSI, TS, DPD, MVD and EGFR With Chemosensitivity in Stage IV in Colorectal Cancer |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | July 2005 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patients recruited met the following eligibility criteria: (1) The sporadic primary colorectal cancer could be palliatively resected and pathologically confirmed as adenocarcinoma; (2) The metastatic lesions were measurable but unresectable; (3) Karnofsky performance status was ≧50%; (4) The life expectancy was greater than 12 weeks; (5) WBC count was ≧4,000/μL, platelet count was ≧100,000/μL, serum bilirubin was ≦2.0 mg/dL, and serum glucose and electrolyte were normal.
Exclusion Criteria:
- Patients with evident family history of colorectal cancer suggestive of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) were excluded from this study. Moreover, patients with evident carcinosis peritonitis were excluded from this study because their bowel function could not be restored through palliative operation and their prognosis was considered as very poor.
Contacts and Locations| Taiwan | |
| Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C. | |
| Taipei, Taiwan, 100 | |
| Principal Investigator: | Jin-Tung Liang, M.D., Ph.D. | Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00173472 History of Changes |
| Other Study ID Numbers: | 9461700674 |
| Study First Received: | September 12, 2005 |
| Last Updated: | November 23, 2005 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
colorectal cancer, MSI, TS, DPD, EGFR, chemotherapy. |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013