Status:
COMPLETED
Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients
Lead Sponsor:
National Cancer Institute, Egypt
Conditions:
Clinical Response
Toxicity
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic increase in efficacy, reduction of mortality, and improvements in survival by the use of standard doses of chem...
Detailed Description
This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University between January 2...
Eligibility Criteria
Inclusion
- Patient age 18-70 years of both sexes.
- PS 0-2 and histologically proven mCRC with unresectable metastases (rectal cancer is included to left side cancers).
- They should have measurable lesions (that can be accurately measured in at least one dimension using calipers or ruler and measurement must be at least 20 mm using conventional techniques or 10 mm using spiral CT scan).
- No previous treatment for metastatic disease and had ended adjuvant treatment \> 6 months.
- peripheral neuritis less than grade 2.
- Normal organ functions:(Creatinine ≤1.2, Bilirubin ≤1.2, SGOT/SGPT\< 2N, HB \>9gm/dl, WBC\>3.5/dl with ANC \>1.5/dl, Plat ≥100/dl).
- For patients with liver metastases, Bilirubin should not be \>2.5N and transaminases not \>5N. (All patients were screened for HCV and HBS Ag by PCR).
- Adequate cardiac functions (EF\>55%)
Exclusion
- patients with only ascites or bone metastasis
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04425564
Start Date
January 1 2016
End Date
December 31 2019
Last Update
June 11 2020
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