Clinical trial · Interventional
SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients
A Prospective Randomized Controlled Trial to Compare Oxaliplatin Combined With S-1 (SOX) Versus Oxaliplatin With Capecitabine (XELOX) as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients
- 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)
Fluorouracil combined with oxaliplatin are routinely recommended to patients with pathological stage III (p-stage III) colorectal cancer, leading to significant improvement of 5-year disease-free survival and overall survival (approximately 3.4% -4.2%) by by international guidelines such as the National Cancer Comprehensive Network. The Considerable proportion of patients suffer with hand-foot syndrome due to capecitabine as commonly prescribed. Meanwhile as another agent of fluorouracil, tegafur,gimeracil and oteracil potassium (short for TGOP) has been shown with similar effect and less adverse reaction. This study was designed to investigate the short-term and long-term safety and efficacy of TGOP-OX and XELOX regimens in colorectal cancer p-stage III patients who undergo curative surgery and adjuvant chemotherapy, and to explore the compliance and quality of life in patients treated with TGOP-OX regime.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Chemotherapy | — | UNRESOLVED | — |
| Colorectal Cancer Stage III | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Tegafur,gimeracil and oteracil potassium | Drug | — | UNRESOLVED |
| Xeloda | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (TGOP-OX)
- description
- Colorectal cancer patients p-staged III are randomized and assigned with TGOP-OX (Tegafur,gimeracil and oteracil potassium+Oxaliplatin) as adjuvant chemotherapy.
- interventionNames
- Drug: Oxaliplatin
- Drug: Tegafur,gimeracil and oteracil potassium
- type
- ACTIVE_COMPARATOR
- label
- Group B (XELOX)
- description
- Colorectal cancer patients p-staged III are randomized and assigned with XELOX (Xeloda+Oxaliplatin) as adjuvant chemotherapy.
- interventionNames
- Drug: Oxaliplatin
- Drug: Xeloda
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written consent form; * age ≥18 years old; * randomization within 2-8 weeks after surgery; * Performance status of the US Eastern Cancer Cooperative Group (ECOG) score 0-1; * pathologically diagnosed as stage III colon or rectal adenocarcinoma patient; * Accept effective contraceptive measures; * postmenopausal women; pregnancy test negative 72 hours before randomization; * R0 resection. Exclusion Criteria: * primary tumor metastasis (including tumor cells in the ascites or the occurrence of peritoneal metastasis); * presence of clinical relevant cardiovascular disease; * presence of disease history of central nervous system, or evidence confirmed subjects suffering from central nervous system diseases; * presence of grade 3 (or over grade 3) peripheral neuropathy, according to the common adverse event evaluation criteria (CTCAE) v. 3.0; * post-operative radiotherapy must be implemented in patients according to researchers' assessment,; * presence of any unresolved toxicity left from previous anti-cancer treatment left \> grade 2 according to CTCAE, except hair loss; * simultaneous use of targeted therapeutic drugs, such as anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-epidermal growth factor receptor (EGFR) monoclonal antibody; * brain metastases or meningeal metastases; * Insufficiency of bone marrow reserve capacity, the presence of neutrophils absolute count ≤ 1.5 × 109 / L or platelet count ≤ 75 × 109 / L, or the need for regular blood transfusion in order to maintain hemoglobin ≥ 9g / dL; * Serum bilirubin ≥1.5 × upper limit of reference range (ULRR); * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 × ULRR; * serum creatinine ≥ 1.5 × ULRR or Cockcroft-Gault formula calculated creatinine clearance ≤ 50ml / min; * Evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes, massive active bleeding); * undergo a major surgery within 14 days prior to entering the study, or surgical incision that has not yet healed completely; * women who are pregnant or breastfeeding, or women who are positive for pregnancy before the trial; * subjects known to be allergic to oxaliplatin, capecitabine, S-1 or any ingredient of these products; * combination of other anti-cancer treatment (including gonadotropin-releasing hormone agonists, anti-cancer Chinese medicine, immunotherapy), except for steroid hormones; * In the past 5 years there are other malignant tumor history, except curative treatment of skin basal cell carcinoma and / or cervical cancer in situ; * have a significant history of gastrointestinal damage, the researchers judge may significantly affect the absorption of S-1, including dysphagia; * subjects known suffering dihydropyrimidine dehydrogenase (DPD) deficiency.
References
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