Severe Neutropenia After HIPEC Using Mitomycin-C (NCT05513183) | Clinical Trial Compass
CompletedNot Applicable
Severe Neutropenia After HIPEC Using Mitomycin-C
South Korea74 participantsStarted 2021-05-20
Plain-language summary
Mitomycin-C (MMC) is the most commonly used chemotherapeutic agent for hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery (CRS) to treat colorectal cancer patients with peritoneal metastases. However, MMC has a side effect of myelosuppression. Particularly, severe neutropenia after CRS with HIPEC can be a life-threatening condition. Despite the postoperative risks of this side effect, the causes and risk factors for severe neutropenia after CRS followed by HIPEC is not identified so far. Therefore, in this study, we aimed to evaluate to evaluate clinical risk factors and pharmacologic properties after CRS with HIPEC using MMC in patients with colorectal cancer or appendiceal mucinous neoplasms with peritoneal metastases.
Who can participate
Age range
20 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:
* Joined the study voluntarily and signed informed consent form
* Patients who diagnosed colorectal cancer or appendiceal mucinous neoplasm with peritoneal metastases
* Patients who undergo CRS/HIPEC using MMC
* ECOG ≤ 1
Exclusion Criteria
* Patients who received synchronous operations for liver or lung metastatic sites during CRS/HIPEC
* Previous histories who underwent CRS/HIPEC
* Patients who received palliative 3rd line chemotherapy
* Patients who received chemotherapy within 1 year to treat other cancers
* Patients who had PCD cathethers for ascites control
* ECOG ≥2
* Infectious status
* Age\<19 years old
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Drop-out criteria
\- Hospital stay \> 30 days
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
Association between the concentration of intraoperative mitomycin-C absoprtion and severe neutropenia after CRS/HIPEC