Hypofractionated intensity-modulated radiation therapy with concurrent chemotherapy in muscle-invasive bladder cancer (HIRACOM)

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0006075

Lead Sponsor: Samsung Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 53

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.)

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two-year bladder preservation disease-free survival rate when concurrent chemo-hypofractionated intensity-modulated radiation therapy

Secondary Outcome Measures

Name	Time	Method
acute toxicity when concurrent chemo-hypofractionated intensity-modulated radiation therapy;late toxicity when concurrent chemo-hypofractionated intensity-modulated radiation therapy;quality of life when concurrent chemo-hypofractionated intensity-modulated radiation therapy;2 year disease-free survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy;ovarall survival when concurrent chemo-hypofractionated intensity-modulated radiation therapy