Radical Colorectal Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer
NCT02830139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-03-18
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.
Conditions
- Malignant Neoplasm of Colorectum
Interventions
- PROCEDURE
-
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.
- PROCEDURE
-
Radical colorectal resection
radical colorectal resection with lymphadenectomy
- DRUG
-
Oxaliplatin , Capecitabine
XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
- DRUG
-
Normal saline , Cisplatin , 5-Fu
Sponsors & Collaborators
-
Wuhan University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2020-03-15
- Completion
- 2020-03-15
Countries
- China
Study Locations
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