Clinical trial · Interventional
Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin
Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
- 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)
Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.
Conditions
Conditions (5)
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 |
| Effects of Chemotherapy | — | UNRESOLVED | — |
| Local Neoplasm Recurrence | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Local radiotherapy | Radiation | — | UNRESOLVED |
| R0 resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant therapy arm
- description
- FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles
- interventionNames
- Drug: Irinotecan
- Drug: 5-fluorouracil
- Radiation: Local radiotherapy
- Procedure: R0 resection
- type
- ACTIVE_COMPARATOR
- label
- Adjuvant therapy arm
- description
- Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy
- interventionNames
- Drug: Irinotecan
- Drug: 5-fluorouracil
- Radiation: Local radiotherapy
- Procedure: R0 resection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age:18-80 * ECOG score: 0 or 1 * Histological confirmed of Colorectal Adenocarcinoma * History of exposure to oxaliplatin * With local recurrent or metastatic focus * Tumor resectable confirmed by at less 3 hepatobiliary surgeon * Informed content acquired Exclusion Criteria: * History of Exposure to Irinotecan * Received surgery in recently 4 weeks or did not recover from surgery * Other history of cancer in recent 5 years * Fluorouracil allergy or dihydropyrimidine dehydrogenase defect * Women with potential pregnancy.
References
Publications (0)
Data not yet available