Clinical trial · Interventional
Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer
- 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 efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.
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 |
|---|---|---|---|
| curative resection for colorectal cancer | Procedure | — | UNRESOLVED |
| intra-operative 5-FU chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM A- surgery alone
- description
- all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.
- interventionNames
- Procedure: curative resection for colorectal cancer
- type
- EXPERIMENTAL
- label
- ARM B surgery plus chemotherapy
- description
- all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.
- interventionNames
- Procedure: curative resection for colorectal cancer
- Drug: intra-operative 5-FU chemotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed as adenocarcinoma of colon and rectum * age 18-75 years * eligible for curative surgical resection * performance score: ECOG 0-1 * normal blood cells counts: WBC ≥ 4.0×10\*9/L，PLT ≥ 100×10\*9/L * normal blood chemistry test: ALT/AST ≤ 2.5 ULN, TBil ≤ 1.5 ULN, BUN ≤ 1.5 ULN,Cr ≤ 1.5 ULN * normal ECG * no history of other malignant tumors * no concomitant anti-cancer therapy Exclusion Criteria: * clinical bowel obstruction * anticipated into another clinical trial within three months * uncontrolled infection, serious internal medical diseases * Pregnant or lactating women * mentally abnormal patients * patients known allergic to 5-FU
References
Publications (1)
- DERIVEDZhang RX, Lin JZ, Lei J, Chen G, Li LR, Lu ZH, Ding PR, Huang JQ, Kong LH, Wang FL, Li C, Jiang W, Ke CF, Zhou WH, Fan WH, Liu Q, Wan DS, Wu XJ, Pan ZZ. Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC). J Cancer Res Clin Oncol. 2017 Dec;143(12):2581-2593. doi: 10.1007/s00432-017-2489-0. Epub 2017 Aug 28. PMID 28849265