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The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.
To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical colorectal resection with lymphadenectomy. Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical colorectal resection without HIPEC | Sham Comparator | Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX) |
|
| Radical colorectal resection with HIPEC | Experimental | Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermic intraperitoneal chemotherapy (HIPEC) | Procedure | Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From the date of surgery to the date of death or to the end of follow-up | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 5 years | |
| distant metastasis rate | 5 years | |
| peritoneal metastasis rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430021 | China |
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| Radical colorectal resection | Procedure | radical colorectal resection with lymphadenectomy |
|
| Oxaliplatin , Capecitabine | Drug | XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14. |
|
| Normal saline , Cisplatin , 5-Fu | Drug |
|
| 5 years |
| local recurrence rate | 5 years |
| complication rate | 5 years |
| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000077330 | Saline Solution |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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