Colorectal Cancer MetastaticNCT05513183
Severe Neutropenia After HIPEC Using Mitomycin-C
An observational study of Colorectal Cancer Metastatic and Cancer Metastatic to the Peritoneal Cavity, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Cancer Metastatic to the Peritoneal Cavity, Appendiceal Neoplasm
- What is being tested?
- Intraoperative blood and peritoneal fluid samplings during HIPEC
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2021to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who diagnosed colorectal or appendiceal neoplasms with peritoneal metastases who underwent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy using mitomycin-C
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
Seoul
About this study
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
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.
Read the detailed description
Evaluation parameters
- 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
- 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)
- 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
- Being tested
- Intraoperative blood and peritoneal fluid samplings during HIPEC
- Medical subject headings
- Appendiceal Neoplasms, Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative blood and peritoneal fluid samplings during HIPECProcedure or surgery
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Severe neutropnia group), | 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). Receives: Procedure: Intraoperative blood and peritoneal fluid samplings during HIPEC | |
| Arm II (No severe neutropenia group) | 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). Receives: Procedure: Intraoperative blood and peritoneal fluid samplings during HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks after the discharge
Secondary outcomes (6)
Incidence of severe neutropenia
Incidence (rates)
Measured: During 2 weeks after CRS/HIPEC
Postoperative complications
Assessment from Clavien-Dindo classification
Measured: During 2 weeks after CRS/HIPEC
Patterns of perioperative changes of WBC, Hemoglobin, platelet, lymphocyte, neutrophil counts
Records for serologic tests
Measured: During 2 weeks after CRS/HIPEC
Frequency of postoperative uses for G-CSF
Numbers of G-CSF uses
Measured: During 2 weeks after CRS/HIPEC
Changes of CEA level
ng/mL
Measured: During 2 weeks after CRS/HIPEC
Quality of Life: QoR-40 questionnaire
Answer of questionnarie
Measured: During 2 weeks after CRS/HIPEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start20 May 2021
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Jung Park, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513183
- Sponsor's protocol ID
- 3-2021-0122
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14551293Katz 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.
PubMed 14567024Kuzuya 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.
PubMed 7815285Lambert 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.
PubMed 19475451Feferman 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.
PubMed 29027153Park 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.
PubMed 34689262Lee 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.
PubMed 34665362
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05513183
- Acronym / sponsor ID
- 3-2021-0122
- Conditions
- Colorectal Cancer Metastatic, Cancer Metastatic to the Peritoneal Cavity, Appendiceal Neoplasm, Pseudomyxoma Peritonei
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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)
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Severe neutropnia group), | – | Procedure: Intraoperative blood and peritoneal fluid samplings during HIPECAfter 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). |
| Arm II (No severe neutropenia group) | – | Procedure: Intraoperative blood and peritoneal fluid samplings during HIPECAfter 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed colorectal or appendiceal neoplasms with peritoneal metastases who underwent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy using mitomycin-C
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | Arm I (Severe neutropnia group),, Arm II (No severe neutropenia group) |
Primary outcome
Association between the concentration of intraoperative mitomycin-C absoprtion and severe neutropenia after CRS/HIPEC
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
6 secondary outcomes
Incidence of severe neutropenia
Time frame: During 2 weeks after CRS/HIPEC
Postoperative complications
Time frame: During 2 weeks after CRS/HIPEC
Patterns of perioperative changes of WBC, Hemoglobin, platelet, lymphocyte, neutrophil counts
Time frame: During 2 weeks after CRS/HIPEC
Frequency of postoperative uses for G-CSF
Time frame: During 2 weeks after CRS/HIPEC
Changes of CEA level
Time frame: During 2 weeks after CRS/HIPEC
Quality of Life: QoR-40 questionnaire
Time frame: During 2 weeks after CRS/HIPEC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 14551293Verwaal 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.
- Background: PubMed 14567024Katz 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.
- Background: PubMed 7815285Kuzuya 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.
- Background: PubMed 19475451Lambert 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.
- Background: PubMed 29027153Feferman 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.
- Background: PubMed 34689262Park 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.
- Background: PubMed 34665362Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic and Cancer Metastatic to the Peritoneal Cavity, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between the concentration of intraoperative mitomycin-C absoprtion and severe neutropenia after CRS/HIPEC (time frame: 2 weeks after the discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05513183, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.