UnknownPhase 3

Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery

300 participantsStarted 2017-08-01

Plain-language summary

This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Histologically-proven colorectal adenocarcinoma
✓. Patients with colon cancer or intraperitoneal rectal cancer with clinical (by CT) T4 tumors, any N, M0
✓. Signed informed consent
✓. White blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
✓. No bleeding diathesis or coagulopathy
✓. Patients without chemotherapy, radiation or other anti-cancer treatment before the clinical trial

Exclusion criteria

✕. Liver and/or lung metastases
✕. Pregnant women or likely to be pregnant
✕. Severe hepatic and / or renal dysfunction
✕. Impossibility of an adequate follow-up
✕. Without history of cancer during last 5 years
✕. Other concurrent chemotherapy
✕. Severe or uncontrolled mental illness
✕. Patients with epilepsy required to be treated

What they're measuring

Incidence of endoperitoneal recurrence at 36 months

Timeframe: 36 months

Trial details

NCT IDNCT03221608

SponsorSixth Affiliated Hospital, Sun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-01

Contact for this trial

MeiJin Huang, MD

86-020-38250745 meijinhuang3@163.com

View on ClinicalTrials.gov More Colorectal Neoplasms trials