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

Hypofractionated intensity-modulated radiation therapy with concurrent chemotherapy in muscle-invasive bladder cancer: A prospective phase II exploratory trial (HIRACOM)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006075

Enrollment

Registered

2021-04-09

Start date

2021-04-19

Completion date

Unknown

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : 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

of the total dose to cover the entire PTV, and the minimum dose in the PTV is not lower than 95&#37

of the prescribed dose, and the maximum dose does not exceed 107&#37

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 (cis

Eligibility

Sex/Gender

All

Inclusion 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

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.)

Design outcomes

Primary

Measure	Time frame
Two-year bladder preservation disease-free survival rate when concurrent chemo-hypofractionated intensity-modulated radiation therapy	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactWon Park

Samsung Medical Center

wonro.park@samsung.com+82-2-3410-2616

Outcome results