Clinical trial · Interventional
Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients
Clinico-pharmacological Study of Metronomic Capecitabine and Oxaliplatin Versus Classic XELOX in Egyptian Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 chemotherapy, some CRC patients suffer from severe toxicities besides disease progression. Use of chemotherapy less than the maximum tolerated dose, with no prolonged drug free breaks incapacitates the cells to engage in progression mechanisms, suggesting that it could be a better alternative to standard dose therapy with better toxicity profile
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Response | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples for pharmacological studies | Other | — | UNRESOLVED |
| Classic XELOX | Drug | — | UNRESOLVED |
| metronomic XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Classic (A)
- description
- patients recieving classic XELOX (oxaliplatin 130mg/m2 and capecitabine 1000mg/m2 bid)
- interventionNames
- Drug: Classic XELOX
- Other: Blood samples for pharmacological studies
- type
- EXPERIMENTAL
- label
- metronomic (B)
- description
- patients recieving low dose capecitabine (2000mg daily divided in two doses for 8 weeks) and oxaliplatin (30mg/m2 weekly for eight weeks) followed by 2 weeks rest.
- interventionNames
- Drug: metronomic XELOX
- Other: Blood samples for pharmacological studies
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * patients with only ascites or bone metastasis
References
Publications (0)
Data not yet available