Clinical trial · Interventional
Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
A Prospective,Multi-Center,Randomized Control Trial of Preoperative Hepatic and Regional Arterial Chemotherapy(PHRAC) Using Oxaliplatin, Fluorodeoxyuridine(FUDR) and Mitomycin C(MMC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
NCT00643877CI-TRIAL-00002158PHRACunknownPhase 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)
The purpose of this study is to investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in 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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR | Procedure | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- B
- description
- PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
- interventionNames
- Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
- type
- NO_INTERVENTION
- label
- A
- description
- Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
- interventionNames
- Procedure: surgery
Primary outcomes (1)
- measure
- 5 years disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 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 * no prior cancer therapy * 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 Exclusion Criteria: * age \>= 75 * severe major organ dysfunction * WHO performance status of \>1 * prior cancer therapy * Stage I or Stage IV
References
Publications (1)
- DERIVEDZhu D, Xia J, Gu Y, Lin J, Ding K, Zhou B, Liang F, Liu T, Qin C, Wei Y, Ren L, Zhong Y, Wang J, Yan Z, Cheng J, Chen J, Chang W, Zhan S, Ding Y, Huo H, Liu F, Sun J, Qin X, Xu J. Preoperative Hepatic and Regional Arterial Chemotherapy in Patients Who Underwent Curative Colorectal Cancer Resection: A Prospective, Multi-center, Randomized Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1066-1075. doi: 10.1097/SLA.0000000000004558. PMID 33214446