NCT05453682Recruiting
Hypofractionated IMRT With Concurrent Chemotherapy in Muscle-invasive Bladder Cancer (HIRACUM)
Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Musc Le-invasive Bladder Cancer:
Source: ClinicalTrials.gov · Last updated 2 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- First submitted
- 29 Dec 2021
- Start date
- 14 May 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Samsung Medical Center
- Diseases
- Bladder cancer
- NCT number
- NCT05453682
What you commit to
- Study type: Interventional
- Planned participants: 53
- From 14 May 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous pelvic radiotherapy history
Other illness
- 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.)
Other
- Pregnant or lactating patients
- Patients with distant metastasis
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.