Clinical trial · Interventional
Low-dose Capecitabine Adjuvant Chemotherapy for Elderly Patients With Stage II/III Colorectal Cancer
Low-dose Versus Standard-dose Capecitabine Adjuvant Chemotherapy for Chinese Elderly Patients With Stage II/III Colorectal Cancer: A Randomized, Phase 3 Non-inferiority 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)
Approximately half of colorectal cancer (CRC) patients were first diagnosed after 70 years old. However, compared with younger patients, elderly patients were often undertreated in chemotherapy due to their impaired tolerance. Recently, there have been great controversy on adjuvant chemotherapy strategy for stage II/III CRC patients. As an oral fluoropyrimidine, capecitabine has been demonstrated to be equivalent to i.v. 5-Fu/leucovorin regimen in stage III CRC patients. In light of fewer adverse effects and better flexibility, capecitabine was regarded as an ideal alternative for elderly CRC patients, but the optimal dosage for stage II/III elderly CRC patients still remains inconclusive. Our trial expected to prospectively randomized 710 postoperative stage II/III elderly CRC patients (between 70 and 90 years of age) to adjuvant mono-chemotherapy with a standard dose of capecitabine (2500 mg/m2/day) or a reduced dose (2000 mg/m2/day). This is a non-inferiority phase 3 trial with a primary endpoint of 3-year disease free survival (DFS), and other outcomes include 3-year overall survival(OS), completion rate, toxic and adverse effects and quality of life(Qol). By this trial, we aimed to achieve more precise evidence on the individualized adjuvant chemotherapy strategy for stage II/III elderly CRC patients.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- standard-dose
- description
- capecitabine, oral administration, 1,250 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- reduced-dose
- description
- capecitabine, oral administration, 1,000 mg/m2 twice daily on days 1-14, and repeated on day 22; 8 circles in total.
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. With informed consents 2. Histologically identified carcinoma of colon and rectum 3. pT3-4NanyM0 or pTanyN+M0(stage II/III) 4. age between 70 to 90 5. undergone R0 resection 6. ECOG ≤2 7. Stage II patients with microsatellite stable (MSS) or microsatellite low (MSL) Exclusion Criteria: 1. With other types of malignances simultaneously 2. Creatinine clearance ≤ 70 ml/min 3. Undergone neoadjuvant chemotherapy 4. In anticoagulant therapy 5. Pregnant or lactating women 6. History of antineoplastic drugs 7. With other contraindications for chemotherapy
References
Publications (14)
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- BACKGROUNDBenson AB 3rd, Schrag D, Somerfield MR, Cohen AM, Figueredo AT, Flynn PJ, Krzyzanowska MK, Maroun J, McAllister P, Van Cutsem E, Brouwers M, Charette M, Haller DG. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol. 2004 Aug 15;22(16):3408-19. doi: 10.1200/JCO.2004.05.063. Epub 2004 Jun 15. PMID 15199089
- BACKGROUNDQuasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2. PMID 18083404
- BACKGROUNDFolprecht G, Cunningham D, Ross P, Glimelius B, Di Costanzo F, Wils J, Scheithauer W, Rougier P, Aranda E, Hecker H, Kohne CH. Efficacy of 5-fluorouracil-based chemotherapy in elderly patients with metastatic colorectal cancer: a pooled analysis of clinical trials. Ann Oncol. 2004 Sep;15(9):1330-8. doi: 10.1093/annonc/mdh344. PMID 15319237
- BACKGROUNDMcCleary NJ, Meyerhardt JA, Green E, Yothers G, de Gramont A, Van Cutsem E, O'Connell M, Twelves CJ, Saltz LB, Haller DG, Sargent DJ. Impact of age on the efficacy of newer adjuvant therapies in patients with stage II/III colon cancer: findings from the ACCENT database. J Clin Oncol. 2013 Jul 10;31(20):2600-6. doi: 10.1200/JCO.2013.49.6638. Epub 2013 Jun 3. PMID 23733765
- BACKGROUNDSchrag D, Cramer LD, Bach PB, Begg CB. Age and adjuvant chemotherapy use after surgery for stage III colon cancer. J Natl Cancer Inst. 2001 Jun 6;93(11):850-7. doi: 10.1093/jnci/93.11.850. PMID 11390534
- Sargent DJ, Goldberg RM, Jacobson SD, Macdonald JS, Labianca R, Haller DG, Shepherd LE, Seitz JF, Francini G. A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med. 2001 Oct 11;345(15):1091-7. doi: 10.1056/NEJMoa010957.