Hypofractionated radiation therapy with chemotherapy for bladder cancer
Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Musc Le-invasive Bladder Cancer:
This study is testing a new way to treat muscle-invasive bladder cancer using a combination of radiation and chemotherapy to see if it helps preserve the bladder while reducing side effects and treatment time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation, Chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05453682 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of concurrent chemotherapy and hypofractionated intensity-modulated radiation therapy (IMRT) on patients with muscle-invasive bladder cancer. Participants will receive a total radiation dose of 56-64 Gy delivered in 20 fractions over 4 weeks, combined with weekly platinum-based chemotherapy. The study aims to evaluate side effects, quality of life, and treatment efficacy, focusing on bladder preservation while minimizing damage to surrounding healthy tissues. The approach seeks to shorten treatment duration while maintaining or improving therapeutic outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with histologically confirmed muscle-invasive bladder cancer who desire bladder conservation.
Not a fit: Patients with distant metastasis, extensive non-invasive/invasive bladder cancer, or those who have previously undergone pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve bladder preservation rates and reduce treatment-related side effects for patients with bladder cancer.
How similar studies have performed: While concurrent chemoradiotherapy has been established, the specific combination of hypofractionated IMRT with chemotherapy is still being explored and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients diagnosed with bladder cancer histologically 2. Patients with muscle layer involvement in transurethral resection (pT2 or higher) 3. Patients without pelvic lymph node metastasis by computed tomography (CT) or magnetic resonance images (MRI) of the pelvis. 4. Patients who want bladder conservation treatment 5. Patients over 20 years old 6. Patients with Zubrod (ECOG) performance status 0-1 within 1 week prior to participation in the study 7. Patients who have signed the consent form with sufficient information by the patient or guardian 8. Patients with hematologic findings capable of concurrent chemoradiotherapy Exclusion Criteria: 1. Patients with previous pelvic radiotherapy history 2. Pregnant or lactating patients 3. Patients with distant metastasis 4. Patients judged to be difficult to conserve bladder due to extensive non-invasive/invasive bladder cancer 5. 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) 6. Patients with untreated severe acute disease 7. Patients predicted to have a high probability of radiation complications due to connective tissue disease (lupus, scleroderma, etc.)
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Won Park, Dr
- Email: wonro.park@samsung.com
- Phone: 82-10-9933-2616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.