Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
Beijing, Changping, 102218, China
Location status: Recruiting
NCT Number: NCT07328737
The goal of this clinical trial is to compare the efficacy and safety of one versus three sessions of hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery (CRS) for patients with pseudomyxoma peritonei (PMP).
The main questions it aims to answer are:
* Does receiving three HIPEC sessions lead to better Progression-Free Survival (PFS) and Overall Survival (OS) compared to one session? * What are the differences in postoperative complications (e.g., infection, bowel obstruction, myelosuppression) and organ toxicity (e.g., liver/kidney injury) between the two regimens? * How do the different treatment schedules impact patients' quality of life?
Researchers will compare the experimental group (3 HIPEC sessions) to the control group (1 HIPEC session) to investigate the efficacy and safety of the additional sessions.
Participants will:
* Be randomly assigned to one of two groups:
1. Control Group: Receive only a single intraoperative HIPEC session following CRS. 2. Experimental Group: Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses. * Undergo scheduled safety checks for side effects on days 1, 3, 5, 7, and 10 post-HIPEC. * Attend a follow-up visit at 1 month after CRS+HIPEC and, if eligible, receive 6 cycles of standard postoperative chemotherapy. * Attend regular long-term follow-up visits for several years, which will include physical examinations, blood tests (for tumor markers), CT scans, and quality-of-life questionnaires (EORTC QLQ-C30 version 3.0).
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Beijing, Changping, 102218, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(5) Radiological Peritoneal Cancer Index (PCI) ≥15; (6) No local or systemic antitumor therapy within 1 month prior to CRS+HIPEC; (7) Adverse reactions from prior treatments have resolved before study initiation or, in the investigator's judgment, will not interfere with this study;
Exclusion criteria
Receive only a single intraoperative HIPEC session following CRS.
Receive two additional HIPEC sessions after CRS+HIPEC (on post-operative day 2 and day 4) at reduced drug doses.
Time frame: From randomization until 12 months postoperatively.
Time frame: From randomization until 1 months postoperatively.
Time frame: From randomization until 3 years postoperatively.
Time frame: From randomization until 3 years postoperatively.
Contact information is provided by the study sponsor or research team.
Beijing Tsinghua Chang Gung Hospital
Other
Efficacy and Safety of One vs Three Cycles of Hyperthermic Intraperitoneal Chemotherapy After Cytoreductive Surgery for Pseudomyxoma Peritonei: A Multicenter Randomized Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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