Division of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
Seoul, South Korea
NCT Number: NCT05513183
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.
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Notify Me20 year and older
All sexes
Observational
Seoul, South Korea
Evaluation parameters
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drop-out criteria
Time frame: 2 weeks after the discharge
Comparison of the pharmacologic association between occurrence of postoperative severe neutropenia, and blood absoprtion rates of MMC and the area-under-the curve (AUC) ratios during HIPEC
Time frame: During 2 weeks after CRS/HIPEC
Incidence (rates)
Time frame: During 2 weeks after CRS/HIPEC
Assessment from Clavien-Dindo classification
Time frame: During 2 weeks after CRS/HIPEC
Records for serologic tests
Time frame: During 2 weeks after CRS/HIPEC
Numbers of G-CSF uses
Time frame: During 2 weeks after CRS/HIPEC
ng/mL
Time frame: During 2 weeks after CRS/HIPEC
Answer of questionnarie
Gangnam Severance Hospital
Other
A Phase II Trial to Analyze Clinical and Pharmacological Properties for Severe Neutropenia After Cytoreductive Surgery Followed by Hyperthermic Intraperitoneal Chemotherapy Using Mitomycin-C
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