Hypofractionated radiation therapy with chemotherapy for bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Won Park, Dr
• Email: wonro.park@samsung.com
• Phone: 82-10-9933-2616

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.