NCT05513183

Severe Neutropenia After HIPEC Using Mitomycin-C

A Phase II Trial to Analyze Clinical and Pharmacological Properties for Severe Neutropenia After Cytoreductive Surgery Followed by Hyperthermic Intraperitoneal Chemotherapy Using Mitomycin-C

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Evaluation parameters 1. Preoperative period * Obtaining informed consent * Assessment of baseline clinical characteristics: vital sign, BMI, BSA, ASA classification, ECOG, CBC, CEA level * Before 1 day of surgery, assessment of QoR-40 questionnaires 2. Intra-operative period * CRS / HIPEC * Assessment for peritoneal cancer index, complete cytoreduction score * HIPEC procedures: HIPEC was performed using MMC 35 mg/m2 at 41-43℃ for 90 min. Following the HIPEC triple method, MMC 35 mg/m2 was mixed with 3L of Physioneal PD-2 1.5% peritoneal dialysis solution and administered into the intraperitoneal cavity at 50% of the dose at the beginning of HIPEC, 25% of the dose at 30 min, and 25% of the dose at 60 min. * Intraoperative samplings of blood and peritoneal fluids during HIPEC : * Blood sampling of 5 ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90, 120 min) * Peritoneal fluid sampling of 5 ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90 min) 3. Postoperative period : Postoperative assessment until the discharge date or postoperative 14th days. * Daily assessment before discharge : vital sign, transfusion, neutropenia occurrence, adverse events, hematologic blood test (CBC, absolute neutrophil count (ANC), postoperative complications, use of G-CSF, ICU admission (If severe neutropenia occurs in the postoperative period, the patient assigns in arm I.) * CEA level: postoperative 5th day * QoR-40 questionnaires: postoperative 4th and 7th days

Conditions

• Colorectal Cancer Metastatic
• Cancer Metastatic to the Peritoneal Cavity
• Appendiceal Neoplasm
• Pseudomyxoma Peritonei

Interventions

Type	Name	Description
PROCEDURE	Intraoperative blood and peritoneal fluid samplings during HIPEC	\- Intraoperative samplings of blood and peritoneal fluids during HIPEC : * Blood sampling of 5ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90, 120 min) * Peritoneal fluid sampline of 5ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90 min)

Timeline

• Start date: 2021-05-20
• Primary completion: 2023-03-20
• Completion: 2023-03-20
• First posted: 2022-08-24
• Last updated: 2023-08-07

Locations

1 site across 1 country: South Korea