Shorter Radiation With Chemotherapy for Muscle-invasive Bladder Cancer
Tests shorter-course radiation with chemotherapy in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Hypofractionated IMRT With Concurrent Chemotherapy in Muscle-invasive Bladder Cancer (HIRACUM)
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Samsung Medical CenterSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Samsung Medical Center
- Trial code
- NCT05453682
- Record updated
- 2 December 2024
- Original description
The purpose of this study is to investigate the side effects, quality of life, and treatment effects of concurrent chemo-hypofractionated intensity-modulated radiation therapy in bladder cancer.Read full original descriptionShow less
Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Musc Le-invasive Bladder Cancer:
The purpose of this study is to investigate the side effects, quality of life, and treatment effects of concurrent chemo-hypofractionated intensity-modulated radiation therapy in bladder cancer.
Twenty fractionation within 4 weeks are performed using hypofractionated intensity-modulated radiation therapy. As for the radiation dose, 2.8-3.2 Gy at a time, total dose 56-64 Gy, to the high-risk target volume, and 2-2.2 Gy at a time, and 40-44 Gy, respectively, to the low-risk target volume. It aims to include more than 97% of the total dose to cover the entire PTV, and the minimum dose in the PTV is not lower than 95% of the prescribed dose, and the maximum dose does not exceed 107% of the prescribed dose. Chemotherapy before and after radiotherapy can be performed depending on the institutional policy. Among radiotherapy, chemotherapy is performed with platinum-based agents (cisplatin, carboplatin, etc.), and is administered once a week for a total of 3 or more.
Inclusion: Patients diagnosed with bladder cancer histologically; Patients with muscle layer involvement in transurethral resection (pT2 or higher); Patients without pelvic lymph node metastasis by computed tomography (CT) or magnetic resonance images (MRI) of the pelvis; Patients who want bladder conservation treatment; Patients over 20 years old; Patients with Zubrod (ECOG) performance status 0-1 within 1 week prior to participation in the study; Patients who have signed the consent form with sufficient information by the patient or guardian; Patients with hematologic findings capable of concurrent chemoradiotherapy.
Exclusion: Patients with previous pelvic radiotherapy history; Patients judged to be difficult to conserve bladder due to extensive non-invasive/invasive bladder cancer; Patients who have not been disease-free for more than 5 years after diagnosis of cancer (excluding thyroid cancer, non-melanoma skin cancer, T1a prostate cancer, and intraepithelial cancer of the cervix); Patients with untreated severe acute disease; Patients predicted to have a high probability of radiation complications due to connective tissue disease (lupus, scleroderma, etc.); Pregnant or lactating patients; Patients with distant metastasis.