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 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT02000050
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically or cytologically confirmed diagnosis of adenocarcinoma of the mid-low rectum (within 12 cm from the anal verge)
2. Stage: lowT2N0, T2N+M0, T3-4 N-/+M0 (N+ = ≥ 3 nodes \>0,5 cm diameter or ≥ 1 nodes \> 1 cm diameter)
3. Age ≥18 and ≤ 80 years
4. ECOG performance status 0-1
5. Patients must have normal organ and marrow function as defined below:
1. \- Leukocytes ≥ 3,000/mL
2. \- Absolute neutrophil count ≥ 1,500/mL
3. \- Platelets ≥ 100,000/mL
4. \- Total bilirubin ≤ 1.5 X ULN
5. \- AST (SGOT)/ALT (SGPT) ≤ 2.5 X ULN
6. \- Creatinine ≤ 1.5 X ULN
6. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
7. Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
1. Metastatic disease
2. Patients who have had any chemotherapy or radiotherapy prior to entering the study
3. Acute or sub-acute gastrointestinal occlusion
4. Participation in another clinical trial, with any investigational agent within 30 days prior the study screening
5. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma, superficial bladder tumor and in situ carcinoma of the uterine cervix)
6. History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study
7. Uncontrolled concomitant illness, including but not limited to: ongoing or active infections; congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance to study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02000050
Study Brief:
Protocol Section:
NCT02000050