Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Musc Le-invasive Bladder Cancer:

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Won Park, Dr
wonro.park@samsung.com
82-10-9933-2616
Time Frame
Start Date: 2021-05-14
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 53
Treatments
Experimental: Hypo IMRT
in muscle invasive bladder cancer, hypofractionated IMRT with chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov

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