Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT03914820
Status:
UNKNOWN
Last Update Posted:
2023-10-27
First Post:
2019-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Study Overview
Official Title:
Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. CHECK STUDY
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHECK
Brief Summary:
This is a phase III randomized, multicenter study with two different arm:
* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.
Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.
Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
Detailed Description:
This is a phase III randomized, multicenter study with two different arm:
* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.
Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
The HIPEC CO2 regimen will be as reported below:
mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.
Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.
* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin
* comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility.
Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
The HIPEC CO2 regimen will be as reported below:
mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes.
Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001437-14 | EUDRACT_NUMBER | None | View |