Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT03422432
Eligibility Criteria:
Inclusion Criteria:
Two groups of patients may be enrolled:
Group 1 patients are identified pre-operatively on radiological imaging, while Group 2 patients are identified post-operative based on histological findings.
All patients diagnosed with adenocarcinoma of the colon and rectum, and either one of the five following risk factors for peritoneal metastases will be considered for inclusion:
1. T4 tumours - in Group 1, this would consist of obvious clinical T4 stage based on preoperative imaging, and in Group 2, this would be on pathological confirmation of a T4 tumour.
2. Krukenburg tumours - Unilateral or bilateral ovarian masses seen on preoperative imaging
3. Perforated tumours - in Group 1, this would consist of patients presenting with perforation on preoperative imaging, and undergoing curative resection, and in Group 2, this would be on pathological or intra-operative confirmation of a perforated tumour.
4. Limited synchronous peritoneal metastases (peritoneal nodules \<1cm in the omentum and/or close to the tumour). Patients with limited peritoneal disease in close proximity to the primary tumour, that may be removed enbloc with the primary resection can be included, but patients with more extensive peritoneal disease and those with extra-peritoneal metastases i.e. liver and/or lung metastases will be excluded from the study.
5. Positive cytology in Group 2 patients
Other inclusion criteria:
1. Patients must be between the ages of 21 and 75 years
2. Patients must be in a stable clinical condition to undergo simultaneous HIPEC after the primary curative colorectal resection
3. Patients must have an ECOG performance status 0 or 1
4. Patients must have normal organ and marrow function as defined below:
i. Absolute neutrophil count \> 1.5 x 109/L ii. Platelets \> 100 x 109/L iii. Haemoglobin \> 9.0g/dl iv. Total bilirubin ≤1.5 x ULN v. AST(SGOT)/ALT(SGPT) \< 3 X institutional ULN vi. Creatinine ≤1.5 x upper limit of normal (ULN) OR vii. Creatinine clearance ≥60 mL/min for patients with creatinine levels \>1.5 x institutional UL e. Patients must have a normal coagulation profile f. Patients must give written informed consent
Exclusion Criteria:
1. Patients who are not fit to give consent for the procedure
2. Patients who are not fit to undergo surgery
3. Patients who are pregnant
4. Patients who have extensive synchronous peritoneal disease
5. Patients with extra-peritoneal metastases i.e. liver and/or lung metastases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT03422432
Study Brief:
Protocol Section:
NCT03422432