Research on radiotherapy in elderly patients with bladder cancer.

JRCT ID: jRCT1020230038

Registered date:11/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bladder cancer
• Date of first enrollment: 01/11/2023
• Target sample size: 60
• Study type: Observational

Outcome(s)

• Primary Outcome: event-free survival

Secondary Outcome

Overall survival (3-year overall survival rate)
Progression pattern
Completion of treatment (%)
Acute and late adverse event rate
Quality of life assessment (FACT-BL, OABSS)
G8.
Comparison of endpoints between treatments where possible

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable

Include criteria

(1) Bladder cancer diagnosed as urothelial carcinoma
(2) cT2-4aN0M0 (UICC 8th edition) on imaging within 56 days prior to registration
(3) Eastern Cooperative Oncology Group (ECOG) PS 0-2
(4) Not scheduled to receive concomitant chemotherapy for bladder cancer (any previous therapy)
(5) Plans to receive radiotherapy that meets the prescribed dose fractions and dose constraints
(6) No history of radiotherapy to the pelvis

Exclude criteria

(1) If the patient has serious physical symptoms that make it difficult for the patient to cooperate in the study
(2) If the patient has serious psychiatric symptoms (severe cognitive dysfunction, severe depression) that make it difficult to cooperate in the study
(3) If the researcher otherwise deems it inappropriate for the patient to participate in the study.

Related Information

• Primary Sponsor: Ariga Hisanori