Malignant Neoplasm of Colorectum
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.
PROCEDURERadical colorectal resection
radical colorectal resection with lymphadenectomy
DRUGOxaliplatin , Capecitabine
XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
DRUGNormal saline , Cisplatin , 5-Fu
Sponsors
Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological proved diagnosis of locally advanced colorectal cancer. * No evidence of distant metastases or peritoneal metastases. * Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage. * Eligible for radical colorectal resection with lymphadenectomy. * Have not received cytotoxic chemotherapy or radiotherapy. * Written informed consent is obtained prior to commencement of trial treatment.
Exclusion criteria
* Existence of distant metastasis or peritoneal metastasis during surgery (M1). * Any previous chemotherapy or radiotherapy * Active systemic infections * Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * Female patients who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | From the date of surgery to the date of death or to the end of follow-up |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | 5 years |
| distant metastasis rate | 5 years |
| peritoneal metastasis rate | 5 years |
| local recurrence rate | 5 years |
| complication rate | 5 years |
Countries
China
Outcome results
None listed