Actively Recruiting
Hypofractionated IMRT With Concurrent Chemotherapy in Muscle-invasive Bladder Cancer (HIRACUM)
Led by Samsung Medical Center · Updated on 2024-12-02
53
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypofractionated IMRT With Concurrent Chemotherapy in Muscle-invasive Bladder Cancer (HIRACUM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with bladder cancer histologically
- Patients with muscle layer involvement in transurethral resection (pT2 or higher)
- Patients without pelvic lymph node metastasis by CT or 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
- Patients who have signed informed consent
- Patients with hematologic findings capable of concurrent chemoradiotherapy
You will not qualify if you...
- Patients with previous pelvic radiotherapy history
- Pregnant or lactating patients
- Patients with distant metastasis
- Patients difficult to conserve bladder due to extensive non-invasive/invasive bladder cancer
- Patients not disease-free for more than 5 years after cancer diagnosis (except certain cancers)
- Patients with untreated severe acute disease
- Patients at high risk of radiation complications from connective tissue diseases (lupus, scleroderma, etc.)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
W
Won Park, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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