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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT02575859
Eligibility Criteria:
Inclusion Criteria:
* pathologically confirmed colorectal carcinoma;
* curative surgery;
* presence of at least one of the following risk-factors for the development of metachronous PM:
* minimal synchronous PM (nodules ≤1cm in the omentum and/or close to the primary tumor), completely resected at the same time as primary tumor;
* synchronous ovarian metastases, also resected at the same time as primary tumor;
* primary tumor either penetrating visceral peritoneum (T4a),
* primary tumor directly invading other organs (T4b);
* signature of an informed consent form.
* intention to start adjuvant systemic therapy and postoperative follow-up;
* performance status ≤2 according to the Eastern Cooperative Oncology Group score;
* no significant co-morbidities.
* no active sepsis
* no impaired cardiac function (history of previous cardiac failure, or ejection fraction \<40%)
* no impaired renal function (serum creatinin \> 1.5 normal value or creatinin clearance \< 60 mL/min);
* no impaired hepatic function (serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, bilirubin \> 1.5 normal value);
* no impaired bone marrow function (leucocytes \< 4000/mm3 ; neutrophils \< 1500/mm3; platelet \< 80000/mm3)
* no impaired lung function (diagnosis of severe chronic obstructive pulmonary disease , or forced expiratory volume at one second \< 50% or a diffusion capacity of lung for carbon monoxide \< 40% age adjusted).
Exclusion Criteria:
* extensive PM (nodules \>1cm, and/or nodules outside the omentum and/or beyond the close vicinity of the primary tumor);
* extra-abdominal/hepatic metastases;
* emergency presentation (bleeding, perforated, or occlusive primary);
* bleeding diathesis or coagulopathy
* history of previous neoplasm during the past three years, excluding skin spinocellular/basocellular carcinoma;
* preoperative pelvic radio-chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02575859
Study Brief:
Protocol Section:
NCT02575859