Clinical trial · Interventional
Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy
A Randomized Phase III Study Investigating the Role of Oxaliplatin Duration (3 Months Versus 6 Months) in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
NCT01092481CI-TRIAL-00038728unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX_12 or CAPOX_8
- description
- 6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
- interventionNames
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- FOLFOX_6 or CAPOX_4
- description
- 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
- interventionNames
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Curatively resected, histologically confirmed colon adenocarcinoma * AJCC/UICC high-risk stage II, stage III colon cancer * Age over 18 years old * Performance status (ECOG scale): 0-1 * Adequate major organ functions * Patients should sign a written informed consent before study entry Exclusion Criteria: * Colon cancer other than adenocarcinoma * Rectal cancer * R1 or R2 resections * Other malignancies within the last 5 years * Symptomatic peripheral sensory neuropathy * Presence of other serious disease * Lactating or pregnant women * Fertile women
References
Publications (1)
- DERIVEDKim ST, Kim SY, Lee J, Yun SH, Kim HC, Lee WY, Kim TW, Hong YS, Lim SB, Baek JY, Oh JH, Ahn JB, Shin SJ, Han SW, Kim SG, Kang SY, Sym SJ, Zang DY, Kim YH, Choi IS, Kang JH, Kim MJ, Park YS. Oxaliplatin (3 months v 6 months) With 6 Months of Fluoropyrimidine as Adjuvant Therapy in Patients With Stage II/III Colon Cancer: KCSG CO09-07. J Clin Oncol. 2022 Nov 20;40(33):3868-3877. doi: 10.1200/JCO.21.02962. Epub 2022 Jun 30. PMID 35772045