Clinical trial · Interventional
Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer
A Prospective,Randomized Control Trial of Intraoperative Intraportal Chemotherapy (5-FU and Oxaliplatin) Combined With Adjuvant Chemotherapy to Prevent Liver Metastasis in Patients Receiving Curative Colorectal Cancer Resection.
NCT01972503CI-TRIAL-00012933unknownPhase 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)
In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.
Conditions
Conditions (3)
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 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU and oxaliplatin | Drug | — | UNRESOLVED |
| colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A
- description
- Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.
- interventionNames
- Drug: 5-FU and oxaliplatin
- Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
- type
- ACTIVE_COMPARATOR
- label
- ARM B
- description
- Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm B, patients accepted curative resection + mFOLFOX6 alone.
- interventionNames
- Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria 1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum 2. WHO performance status of 0 or 1 3. 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) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan 4. Written informed consent for participation in the trial. Exclusion criteria 1. has prior other malignant cancer 2. has severe major organ dysfunction 3. has prior cancer therapy before surgery
References
Publications (1)
- DERIVEDChang W, Wei Y, Ren L, Zhong Y, Yu Y, Chen J, Zhu D, Ye L, Qin C, Zhao N, Niu W, Qin X, Xu J. Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer. Ann Surg. 2016 Mar;263(3):434-9. doi: 10.1097/SLA.0000000000001374. PMID 26465781