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No enrolled patients received the second surgery.
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The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.
To determine the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer, patients undergo HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exploratory laparoscopy or laparotomy | Procedure | Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| radical resection rate | The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| the Peritoneal Cancer Index score | The score range from 0 to 39, higher values represent a worse outcome | 3 months |
| overall survival | The overall survival time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan University | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D007813 | Laparotomy |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| HIPEC | Procedure | Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min. |
|
| Systemic chemotherapy | Drug | Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week |
|
| 3 years |
| complication rate | The rate of adverse complication | 3 years |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |