Clinical trial · Interventional
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study
- 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)
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes). Bloodsamples will be collected and frozen and later examined for potential predictive factors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| C04.588.274.476.411.307 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine (Xeloda) | Drug | Capecitabine | ALIAS |
| Oxaliplatin (Eloxatin) | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Standard XELOX
- interventionNames
- Drug: Oxaliplatin (Eloxatin)
- Drug: Capecitabine (Xeloda)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Chronomodulated XELOX
- interventionNames
- Drug: Oxaliplatin (Eloxatin)
- Drug: Capecitabine (Xeloda)
Primary outcomes (1)
- measure
- Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven adenocarcinoma of the colon or rectum * Measurable or non-measurable disease * Performance status 0-2 * Adequate renal and hepatic functions * Adjuvant chemotherapy must have ended 180 days before inclusion * Written informed consent prior to randomization Exclusion Criteria: * Prior treatment with Eloxatin or Xeloda * Peripheral neuropathy * Evidence of CNS metastasis * Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months) * Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer * Administration of any other experimental drug under investigation within 2 weeks before randomisation * Pregnant or breast feeding women * Fertile patients must use adequate contraceptives
References
Publications (2)
- BACKGROUNDPfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6. doi: 10.1080/02841860310015894. PMID 14968944
- DERIVEDBoisen MK, Johansen JS, Dehlendorff C, Larsen JS, Osterlind K, Hansen J, Nielsen SE, Pfeiffer P, Tarpgaard LS, Hollander NH, Keldsen N, Hansen TF, Jensen BB, Jensen BV. Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer. Ann Oncol. 2013 Oct;24(10):2554-2559. doi: 10.1093/annonc/mdt253. Epub 2013 Jul 17. PMID 23864097