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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT05688033
Eligibility Criteria:
Inclusion Criteria:
1. Patients with rectal adenocarcinoma
2. Clinical staged T3/4 or any node-positive disease
3. Age of 18-75 years
4. Karnofsky Performance Status \> 80
5. Adequate bone marrow reserve, renal and hepatic functions
6. Without previous antitumoural chemotherapy
7. No evidence of metastatic disease
8. Written informed consent before randomization
9. UGT1A1's genotype of 6/6 or 6/7
Exclusion Criteria:
1. Clinical staged I or IV
2. Age of \<18 or \>75 years
3. Karnofsky Performance Status \< 80
4. Previous pelvis radiotherapy
5. Previous antitumoural chemotherapy
6. Clinically significant internal disease
7. Refuse to write informed consent before randomization
8. UGT1A1's genotype of 7/7
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05688033
Study Brief:
Protocol Section:
NCT05688033