Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery (NCT03221608) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of endoperitoneal recurrence at 36 months
Timeframe: 36 months
Trial details
NCT IDNCT03221608
SponsorSixth Affiliated Hospital, Sun Yat-sen University