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:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT02694718
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor
* Eastern Cooperative Oncology Group performance status 0-2
* Adequate values of laboratory parameters
Exclusion Criteria:
* Evidence of distant metastases
* Previous Chemotherapy or immunotherapy for colorectal cancer
* Previous radiotherapy to the pelvis
* Pre-existing condition which would deter radiotherapy
* Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix
* Clinically significant cardiac disease or myocardial infarction within the last 12 months
* Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
* Organ allografts
* Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues
* Dihydropyrimidine dehydrogenase (DPD) deficiency
* History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02694718
Study Brief:
Protocol Section:
NCT02694718