Clinical trial · Interventional
Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles
A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles
NCT00868816CI-TRIAL-00002157completedPhase 4ClinicalTrials.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)
The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12 cycles of oxaliplatine based adjuvant chemotherapy | Drug | — | UNRESOLVED |
| 8 cycles of oxaliplatine based adjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 12 cycles of oxaliplatine based adjuvant chemotherapy
- interventionNames
- Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 8 cycles of oxaliplatine based adjuvant chemotherapy
- interventionNames
- Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- 5 years after operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age \< 75 years with histologically proven adenocarcinoma of the colon or rectum * no severe major organ dysfunction * WHO performance status of 0 or 1 * Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) Exclusion Criteria: * age \>= 75 * severe major organ dysfunction * WHO performance status of \>1 * Stage I or Stage IV
References
Publications (0)
Data not yet available
No reference posted for this study.