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 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT05295992
Eligibility Criteria:
Inclusion Criteria:
1. Histologically proven bladder cancer
2. Urothelial carcinoma
3. Age ≥ 18 years
4. Stage T1b-T4AN0M0
5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
6. Suitable for radiotherapy
7. ECOG/WHO performance status 0-2
8. Written informed consent
9. For Cohort B, participant's must have normal organ and marrow function as defined below:
* leukocytes ≥2,500/mcL
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/mcL
* hemoglobin ≥9 g/dL
* total bilirubin ≤ 1,5 ULN
* AST(SGOT)/ALT(SGPT) ≤3 × ULN
* alkaline phosphatase ≤2.5 × ULN
* creatinine clearance \<25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance \<50 ml/min.
* INR and aPTT £1.5 ULN
Exclusion Criteria:
1. Prior pelvic radiation therapy
2. Inability to comply with the protocol
3. Presence of a hip prothesis
4. Grade 2 or greater baseline diarrhea
5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05295992
Study Brief:
Protocol Section:
NCT05295992