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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT02639403
Eligibility Criteria:
Inclusion Criteria:
* (i) rectal adenocarcinoma with obstructive symptoms not amenable for curative treatment due to synchronous metastases or patient inoperable due to age and/or comorbidities;
* (ii) symptoms of colorectal obstruction (progressive constipation with abdominal pain arising from less than 2 months, vomiting and/or diarrhea) and/or signs of obstruction at radiological examinations (presence of air-fluid levels or the presence of distended colon upstream neoplastic stenosis of the rectum);
* (iii) candidates for derivative colostomy;
* (iv) bi-dimensionally measurable disease;
* (v) Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
* (vi) able to provide a written informed consent.
Exclusion Criteria:
* (i) RT within 6 months in the same anatomical area before the initiation of study treatment;
* (ii) clinically detectable ascites;
* (iii) pregnancy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02639403
Study Brief:
Protocol Section:
NCT02639403