Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendiceal Neoplasm | Appendix Neoplasm | ALIAS | 0.90 |
| Cancer Metastatic to the Peritoneal Cavity | — | UNRESOLVED | — |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Pseudomyxoma Peritonei | Pseudomyxoma Peritonei | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative blood and peritoneal fluid samplings during HIPEC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm I (Severe neutropnia group),
- description
- After CRS followed by HIPEC using MMC of 35mg/m2, patients who had absolute neutrophil count (ANC) \< 1000/mm3 during the postoperative period are assigned as experimental group (Arm I, severe neutropnia group).
- interventionNames
- Procedure: Intraoperative blood and peritoneal fluid samplings during HIPEC
- label
- Arm II (No severe neutropenia group)
- description
- After CRS followed by HIPEC using MMC of 35mg/m2, patients who had ANC ≥ 1000/mm3 during the postoperative period are assigned as the control group (Arm II: no severe neutropenia group).
- interventionNames
- Procedure: Intraoperative blood and peritoneal fluid samplings during HIPEC
Primary outcomes (1)
- measure
- Association between the concentration of intraoperative mitomycin-C absoprtion and severe neutropenia after CRS/HIPEC
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDVerwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. 2003 Oct 15;21(20):3737-43. doi: 10.1200/JCO.2003.04.187. PMID 14551293
- BACKGROUNDKatz MH, Barone RM. The rationale of perioperative intraperitoneal chemotherapy in the treatment of peritoneal surface malignancies. Surg Oncol Clin N Am. 2003 Jul;12(3):673-88. doi: 10.1016/s1055-3207(03)00034-6. PMID 14567024
- BACKGROUNDKuzuya T, Yamauchi M, Ito A, Hasegawa M, Hasegawa T, Nabeshima T. Pharmacokinetic characteristics of 5-fluorouracil and mitomycin C in intraperitoneal chemotherapy. J Pharm Pharmacol. 1994 Aug;46(8):685-9. doi: 10.1111/j.2042-7158.1994.tb03883.x. PMID 7815285
- BACKGROUNDLambert LA, Armstrong TS, Lee JJ, Liu S, Katz MH, Eng C, Wolff RA, Tortorice ML, Tansey P, Gonzalez-Moreno S, Lambert DH, Mansfield PF. Incidence, risk factors, and impact of severe neutropenia after hyperthermic intraperitoneal mitomycin C. Ann Surg Oncol. 2009 Aug;16(8):2181-7. doi: 10.1245/s10434-009-0523-4. Epub 2009 May 28. PMID 19475451
- BACKGROUNDFeferman Y, Bhagwandin S, Kim J, Aycart SN, Feingold D, Labow DM, Sarpel U. Conflicting Data on the Incidence of Leukopenia and Neutropenia After Heated Intraperitoneal Chemotherapy with Mitomycin C. Ann Surg Oncol. 2017 Dec;24(13):3831-3836. doi: 10.1245/s10434-017-6112-z. Epub 2017 Oct 12. PMID 29027153
- BACKGROUNDPark EJ, Lee SJ, Baik SH. ASO Author Reflections: Delayed Occurrence and Postoperative Risks of Mitomycin-C-Induced Neutropenia After Hyperthermic Intraperitoneal Chemotherapy. Ann Surg Oncol. 2022 Mar;29(3):2087-2088. doi: 10.1245/s10434-021-11000-2. Epub 2021 Oct 23. No abstract available. PMID 34689262