Colorectal Cancer Metastatic Clinical Trial
Official title:
A Phase II Trial to Analyze Clinical and Pharmacological Properties for Severe Neutropenia After Cytoreductive Surgery Followed by Hyperthermic Intraperitoneal Chemotherapy Using Mitomycin-C
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 |
Verified date | August 2023 |
Source | Gangnam Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gangnam Severance Hospital |
Korea, Republic of,
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
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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