drugset / Trial / NCT02402972
A Multi-center Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer
Phase 3
Unknown
700 enrolled
Xu jianmin
Ruijin Hospital · collabThe Second Affiliated Hospital of Harbin Medical University · collabZhejiang University · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
To investigate whether intraoperative intraportal chemotherapy combined with adjuvant chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative colorectal cancer resection compared with adjuvant chemotherapy alone. This is a prospective, blind (doctors who done outcome measures were masked), multi-center, 2-arm randomized controlled trial.
Timeline
- Start
- 2015-02
- Primary completion
- 2020-02
- Completion
- 2022-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 100 mg | Other |
| Subject | fluorodeoxyuridine (FUDR) | Unknown | 1000 mg | Other |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2000 mg/m2 | Intravenous |