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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05513183
Other study ID # 3-2021-0122
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2021
Est. completion date March 20, 2023

Study information

Verified date August 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date March 20, 2023
Est. primary completion date March 20, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

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)

Locations

Country Name City State
Korea, Republic of Division of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea Seoul

Sponsors (1)

Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

Feferman 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. — View Citation

Katz 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. — View Citation

Kuzuya 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. — View Citation

Lambert 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. — View Citation

Lee SJ, Jeon Y, Lee HW, Kang J, Baik SH, Park EJ. Impact of Mitomycin-C-Induced Neutropenia after Hyperthermic Intraperitoneal Chemotherapy with Cytoreductive Surgery in Colorectal Cancer Patients with Peritoneal Carcinomatosis. Ann Surg Oncol. 2022 Mar;29(3):2077-2086. doi: 10.1245/s10434-021-10924-z. Epub 2021 Oct 19. — View Citation

Park 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. — View Citation

Verwaal 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Association between the concentration of intraoperative mitomycin-C absoprtion and severe neutropenia after CRS/HIPEC 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 2 weeks after the discharge
Secondary Incidence of severe neutropenia Incidence (rates) During 2 weeks after CRS/HIPEC
Secondary Postoperative complications Assessment from Clavien-Dindo classification During 2 weeks after CRS/HIPEC
Secondary Patterns of perioperative changes of WBC, Hemoglobin, platelet, lymphocyte, neutrophil counts Records for serologic tests During 2 weeks after CRS/HIPEC
Secondary Frequency of postoperative uses for G-CSF Numbers of G-CSF uses During 2 weeks after CRS/HIPEC
Secondary Changes of CEA level ng/mL During 2 weeks after CRS/HIPEC
Secondary Quality of Life: QoR-40 questionnaire Answer of questionnarie During 2 weeks after CRS/HIPEC
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